Registration Dossier

Administrative data

Description of key information

No data are available for the target substance Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt. Therefore, read-across from structural analogue substances has been applied.

Oral LD50 (equivalent/similar OECD guideline 401), rat: 1200 mg/kg bw

Read-across from structural analogue source substances Sulfuric acid, mono (2-ethylhexyl) ester, sodium salt (CAS 126-92-1) and Sodium dodecyl sulfate (CAS 151-21-3)

Dermal LD50 (OECD guideline 402), rat: > 2000 mg/kg bw (limit test)

Read-across from structural analogue source substance Sodium octyl sulfate (CAS 142-31-4)

Acute toxicity by inhalation was not tested according to REGULATION (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to Guideline study with acceptable restrictions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
e.g. limited data on test substance
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif RAI f
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
100, 1000, 3000, 6000, 7000, 8000, 10000, 12000 and 15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 570 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 840 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only limited information are available.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Doses:
5000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study. Limited information concerning test conditions, dose levels as well as experimental methods and results.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
Limited information concerning test conditions, dose levels as well as experimental methods and results.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 210 g (males), 164 g (females)
- Fasting period before study: animals were fasted approximately 16 h prior to dosing.
Route of administration:
oral: gavage
Vehicle:
water
Doses:
ascending doses of the test substance in aqueous solution (no details on individual dose levels)
No. of animals per sex per dose:
5-10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed for mortality 4 to48 h after application of the respective dose levels.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
After application of the substance at different dose levels, statistical analysis (no details) on the test results was performed to determine the oral LD50 value in male and female rats.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
977 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 427 mg/kg bw
Based on:
test mat.
Mortality:
Mortality was observed in several animals after application of the test substance solution. However, no details were provided on the number of dead animals as well as the dose levels and time points, at which mortalities occurred.
Clinical signs:
Diarrhoea, spastic gait, decreased activity, lateral position, hunched posture, laboured respiration, coma and death were observed in a dose-depend manner.
Body weight:
No details on body weights after test substance application were provided.
Gross pathology:
Necropsy of dead animals showed haemorrhages in gastro-intestinal tract and vascular congestion in the liver. However, no details on the dose levels were provided, at which these effects were observed.
Necropsy of survivors at the end of the 14-day observation period did not reveal any treatment-related adverse effects.
Interpretation of results:
other: Acute tox. oral 4, H302. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
Executive summary:

The acute oral toxicity key study conducted with C12AS Na (CAS 151-21-3) was performed in Wistar rats according to OECD Guideline 401 with acceptable restrictions (BASF, 1983). Both sexes were dosed with the test substance diluted in water at ascending dose levels via gavage. Mortalities occurred but no details regarding dose levels were specified in the study report. Clinical signs of toxicity after test substance application comprised diarrhoea, spastic gait, decreased activity, lateral position, hunched posture, laboured respiration and coma. Necropsy of dead animals revealed haemorrhages in gastro-intestinal tract and vascular congestion in the liver. No findings were observed at necropsy of the surviving animals at the end of the 14-day observation period. Based on statistical evaluation of the results, the LD50 was determined to be 977 mg/kg bw for females and 1427 mg/kg for males. The LD50 for males and females was established at 1200 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 200 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Acute toxicity by inhalation was not tested according to REGULATION (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2.

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 June 2012 - 30 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study conducted in compliance with GLP regulations
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Details on strain: Wistar / Crl:WI (Han) SPF
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks (males) and 13 weeks (females), respectively
- Weight at study initiation: mean (males): 273.0 ± 6.63 g; mean (females): 225.8 ± 3.19 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III
- Diet (ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (ad libitum): Tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
deionized water
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: about 40 cm² (corresponds to at least 10% of the body surface)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.71 mL/kg bw
- Concentration (if solution): 35 g/100 mL
- Constant volume or concentration used: yes
- For solids, paste formed: no
- Form of application: solution in deionized water
- Test item preparation and homogenization: For better handling the test item was ground with mortar and pestle. The test item preparation was produced shortly before application by stirring with a magnetic stirrer.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.

Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.
The evaluation of skin reactions was performed according to Draize, J.H. (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.

Body weight: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.

Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
Males:
The mean body weight of the male animals increased within the normal range throughout the study period.

Females:
The mean body weight of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of observation period.
Other findings:
Local effects:
No local effects were observed.

Body weight changes:

Individual body weight changes

Dose [mg/kg bw]

2000

Sex

male

Animal No.

1

2

3

4

5

mean

sd.

Body weight at study day [g]

 

 

 

 

 

 

 

0

274

267

282

266

276

273.0

6.63

7

278

284

301

281

285

285.8

8.93

14

307

304

330

299

308

309.6

11.93

 

Individual body weight changes

Dose [mg/kg bw]

2000

Sex

female

Animal No.

1

2

3

4

5

mean

sd.

Body weight at study day [g]

 

 

 

 

 

 

 

0

224

222

230

225

228

225.8

3.19

7

231

220

234

226

230

228.2

5.40

14

237

238

240

239

238

238.4

1.14

sd. = standard deviation

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Standard Procedure #10, Rabbit Acute Percutaneous Toxicity Studies
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 animals instead of 5 animals were used.The observation period was 72 h instead of 14 d. The test substance was applied under occlusive instead of semi-occlusive conditions.
Principles of method if other than guideline:
Three male and three female New Zealand Albino rabbits each in the weight range of 2200-2800 g constitute a test group. Animals are randomized into groups according to sex and weight. Areas on the animals' backs approximating 10% of the total body surface are clipped prior to treatment with an Oster small animal clipper. The backs of three animals (2 females, 1 male) are abraded and three (2 males, 1 female) are left intact. Abrading is accomplished with a clipper head which produces minor incisions through the stratum corneum which are not deep enough to produce bleeding.
2 g/kg of the undiluted test material are applied to the test sites and spread with a tongue depressor over the clipped area. A material in dry form may be moistened, if necessary. The test material is covered with a layer of gauze and covered with a rubber dam and secured in place by several wrappings of 3 inch Elastoplast tape. The animals are placed in harnesses to prevent removal of the bandage and test material.
The harnesses and wrappings are removed after 24 hours. At this time the skin is evaluated for degree of irritation. Daily observations are made and recorded for 14 days thereafter. On the fourteenth day the animals are counted, weighed and sacrificed. If deaths were to occur due to this test procedure, an LD50 value could be determined. In our experience, however, with the types of materials that we test, this does not occur so that the test provides information relative to primary irritation.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
No data.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10%
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
Duration of exposure:
24 h
Doses:
2 g/kg bw (corresponding to 500 mg a.s./kg bw)
No. of animals per sex per dose:
3
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
act. ingr.
Mortality:
None
Clinical signs:
Severe erythema and slight eschar formation at 24 h; necrosis by Day 2–14 with sloughing of the skin by Day 8–14; hyper-pigmentation of new skin by Day 14; no signs of systemic toxicity.
Body weight:
Decrease in body weight (220 g) during 14 d observation period in one rabbit with intact skin.
Gross pathology:
No data
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Standard Procedure #10, Rabbit Acute Percutaneous Toxicity Studies
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 animals instead of 5 animals were used. The observation period was 72 h instead of 14 d. The test substance was applied under occlusive instead of semi-occlusive conditions.
Principles of method if other than guideline:
Three male and three female New Zealand Albino rabbits each in the weight range of 2200-2800 g constitute a test group. Animals are randomized into groups according to sex and weight. Areas on the animals' backs approximating 10% of the total body surface are clipped prior to treatment with an Oster small animal clipper. The backs of three animals (2 females, 1 male) are abraded and three (2 males, 1 female) are left intact. Abrading is accomplished with a clipper head which produces minor incisions through the stratum corneum which are not deep enough to produce bleeding.
2 g/kg of the undiluted test material are applied to the test sites and spread with a tongue depressor over the clipped area. A material in dry form may be moistened, if necessary. The test material is covered with a layer of gauze and covered with a rubber dam and secured in place by several wrappings of 3 inch Elastoplast tape. The animals are placed in harnesses to prevent removal of the bandage and test material.
The harnesses and wrappings are removed after 24 hours. At this time the skin is evaluated for degree of irritation. Daily observations are made and recorded for 14 days thereafter. On the fourteenth day the animals are counted, weighed and sacrificed. If deaths were to occur due to this test procedure, an LD50 value could be determined. In our experience, however, with the types of materials that we test, this does not occur so that the test provides information relative to primary irritation.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
No data.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10%
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
Duration of exposure:
24 h
Doses:
2 g/kg bw (corresponding to 500 mg a.s./kg bw)
No. of animals per sex per dose:
3
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
act. ingr.
Mortality:
None
Clinical signs:
Severe erythema and eschar formation at 24 h; necrosis by Day 5–21; necrotic tissues sloughed and leaving skin hyper-pigmented at Day 21; no further signs of systemic toxicity than body weight changes.
Body weight:
Weight loss in all except one rabbit.
Gross pathology:
No data
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.9 kg
No further data are available.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 25% (abraded and shaved)
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
Duration of exposure:
24 h
Doses:
2 g/kg bw (corresponding to 500 mg a.s./kg bw)
No. of animals per sex per dose:
3
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
act. ingr.
Mortality:
None
Clinical signs:
Moderate to severe erythema, edema, and atonia were observed in all animals during this study. By Day 6 of the study, all animals showed signs of desquamation and fissuring. Five animals were observed to have moderate to marked desquamation and one animal had slight desquamation. Moderate to marked fissuring was noted in all animals in this study. In addition, all animals had eschar formation and exfoliation. Signs of dermal irritation were evident in all six anmals at the termination of this study.
Body weight:
No weight losses.
Gross pathology:
No data
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Additional information

There are no study data on acute oral and dermal toxicity available for Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt. Therefore, these endpoints are covered by read across to structurally related alkyl sulfates (AS) in accordance with Regulation (EC) No. 1907/2006 Annex XI 1.5 “Grouping of substances and read-across approach”. In Annex XI 1.5 it is given that a read-across approach is possible for substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS read-across approach show structural similarity. The most important common structural feature of the source and target substances is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the source and target substances in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS have similar physico-chemical, environmental and toxicological properties. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

Acute oral toxicity

Regarding the acute oral toxicity, there are reliable and adequate studies available for the read-across substances Sulfuric acid, mono (2-ethylhexyl) ester, sodium salt (C8-iso AS Na, CAS 126-92-1) and Sodium dodecyl sulfate (C12 AS Na, CAS 151-21-3). All available studies are accounted for in a Weight-of-Evidence (WoE) approach.

The study with C8-iso AS Na (CAS 126-92-1, analytical purity 37.5%) addressing acute oral toxicity was conducted similar to OECD Guideline 401 on Tif RAIf rats (BASF, 1978a). Ten animals of each sex were dosed with the test substance in carboxymethyl cellulose at 100, 1000, 3000, 6000, 7000, 8000, 10000, 12000 and 15000 mg/kg bw via gavage. The LD50 was given as 7570 mg/kg bw for males and females based on the test material. Thus, the LD50 based on the active ingredient is 2840 mg/kg bw for males and females.

The acute oral toxicity study conducted with C12 AS Na (CAS 151-21-3) was performed according to OECD Guideline 401 with acceptable restrictions on Wistar rats (BASF, 1983). The concentration of the test material was >98%. Both sexes were dosed with the test substance via gavage. Mortalities occurred but no further details were available. Clinical signs of toxicity comprised diarrhoea, spastic gait, decreased activity, lateral position, hunched posture, laboured respiration and coma. Necropsy of dead animals revealed haemorrhages in gastro-intestinal tract and vascular congestion in the liver. No findings were observed at necropsy of the surviving animals at the end of the 14-day observation period. Based on statistical evaluation of the results, the LD50 was determined to be 977 mg/kg bw for females and 1427 mg/kg bw for males. The LD50 for males and females was 1200 mg/kg bw

A second study conducted with C12 AS Na (CAS 151-21-3, analytical purity 30%) was performed similar to OECD Guideline 401 (BASF, 1976a). 5 Wistar rats of each sex were dosed with the test substance at the limit dose of 5000 mg/kg bw via gavage and observed for mortalities and behaviour for 14 days. Mortalities occurred 24 hours (2/5 males) and 3 days after treatment (1/5 females). No depression of animals was observed during the post exposure period. The LD50 was determined to be greater than 5000 mg/kg bw based on the test substance and greater than 1500 mg/kg bw based on the active ingredient.

Of the three available values reported above, the most sensitiv one, i.e., LD50 of 1200 mg/kg bw obtained with the RA substance C12 AS Na CAS 151-21-3 was retained with respect to the target substance in terms of hazard assessment and for C&L purposes. The value is considered to be conservative in order to reflect any possible hazard related to acute oral toxicity.

In conclusion the data justify the classification of the target substance Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt as Acute Tox. 4, H302, for oral acute toxicity according to the criteria of Regulation (EC) No. 1272/2008 (CLP).

Acute dermal toxicity

Regarding the acute dermal toxicity one relevant key study with Sodium octyl sulfate (C8 AS Na, CAS 142-31-4) and three supporting studies with further structurally analogue read-across source substances Sulfuric acid, mono-C10-16-alkyl esters, ammonium salts (C10-16 AS NH4, CAS 68081-96-9), Sulfuric acid, mono-C10-16-alkyl esters, magnesium salts (C10-16 AS Mg, CAS 68081-97-0) and Sulfuric acid, mono-C12-13-alkyl esters, potassium salts (C12-13 AS K, CAS 91783-22-1) are available.

The key study was conducted with C8 AS Na (CAS 142-31-4) according to OECD Guideline 402 (BASF, 2012a). Five Wistar rats per sex were treated with 200 mg/kg bw of the test material applied to the skin under semi-occlusive conditions for 24 h. No mortality occurred, no sign of systemic toxicity and of local irritation was observed. Therefore, an LD50 for acute dermal toxicity of > 2000 mg/kg bw was determined.

The study conducted with C10-16 AS NH4 (CAS 68081-96-9) was performed as limit test conducted similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (P&G, 1975a). The test substance (analytical purity 25.1%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Skin reactions were noticed, which comprised severe erythema and slight eschar formation at 24 h, necrosis by day 2–14 with sloughing of the skin by day 8–14 and hyper-pigmentation of new skin by day 14. No signs of systemic toxicity were observed. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater than 500 mg/kg bw based on the active ingredient.

The study conducted with C10-16 AS Mg (CAS 68081-97-0) was performed as limit test conducted similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (P&G, 1975b). The test substance (analytical purity 23.5%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Skin reactions were noticed, which comprised severe erythema and eschar formation at 24 h, necrosis by Day 5–21 and necrotic tissues sloughed and leaving skin hyper-pigmented at Day 21. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

Another study similar to OECD Guideline 402 was performed with C12-13 AS K (CAS 91783-22-1) on three male and three female New Zealand White rabbits (P&G, 1978a). Both sexes were dosed at 2000 mg/kg bw (analytical purity 25%) under occlusive conditions for 24 h. No mortalities occurred during the conduct of the study. Findings within this study comprised moderate to severe erythema, edema, and atonia, desquamation and fissuring by day 6 and eschar formation as well as exfoliation. Since no mortality occurred, the LD50 is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

In conclusion the data justify a non-classification of the target substance Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt for dermal acute toxicity according to the criteria of Regulation (EC) No. 1272/2008 (CLP).

Acute inhalation toxicity

No studies for acute inhalation toxicity are available. However, testing the potential of acute toxicity via inhalation route of Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt is considered not to be justified. According to Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. As information under 8.5.3 (dermal route) is provided, the requirement is fulfilled by using the most appropriate route of exposure. Moreover, AS are mainly used in liquid media and due to their very low vapour pressure [2] inhalation is not expected to be a significant route of exposure. Inhalation of AS may occur by inhalation of aerosols generated by spray cleaners or by inhalation of detergent dusts (e.g. washing powder). Taken into account that the acute toxicity of AS is generally low no further information on acute toxicity is expected by testing for acute inhalation toxicity as the predominant effect will comprise of local irritation rather than systemic toxicity.

 

[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf

Justification for classification or non-classification

While the available data on acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP), data on acute oral toxicity indicate that the target substance Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt has to be classified as Acute tox. oral 4, H302. No information regarding acute inhalation toxicity is available.