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Administrative data

Description of key information

Oral LD50 (OECD 401), rat = 2870 mg/kg bw
Dermal LD50 (OECD 402), rat > 2000 mg/kg bw (limit test)
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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Only limited information on the test material are available.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000, 3200, 4000, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 870 mg/kg bw
Based on:
act. ingr.
Mortality:
There were deaths among animals dosed at 4000 and 5000 mg/kg bw.
Clinical signs:
other: Signs of reaction to treatment observed in all rats that survived for more than one hour after dosing were piloerection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and diarrhoea. These were accompanied by: - decreased re
Gross pathology:
No effects.
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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
other: The animals showed mild clinical signs (increased activity and piloerection) as a reaction for treatment for about 4 hours after dosing.
Gross pathology:
No effects.
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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Rangefinder for OECD 401.
Principles of method if other than guideline:
Rangefinder for OECD 401.
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
0.5, 1.0, 2.0, 5.0, 10.0 mL/kg bw
No. of animals per sex per dose:
1
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 700 mL/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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Limit test:
yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 750 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
study cannot be used for classification
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
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:
> 540 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
study cannot be used for classification
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only basic data given.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study was conducted prior to implementation of GLP.
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
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:
> 1 380 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
study cannot be used for classification
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Limit test:
yes
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:
> 540 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
study cannot be used for classification
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 870 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:
supporting study
Study period:
29 Dez 1977 - 13 Feb 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- 3 males and 3 females were dosed for each test substance instead of 5 males and 5 females
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Isaacs lab stock
- Weight at study initiation: P0304 - male - 2.30 - 2.55 kg, female - 2.83 - 3 kg; P0305 - male - 2.16 - 2.79 kg, female - 2.37 - 2.62 kg
-- Housing: Individually in stainless cages with stainless steel slatted flooring
- Diet: Purina lab rabbit chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 to 20.5°C
- Photoperiod (hrs dark / hrs light): 12 hours on/off flurescent lighting

IN-LIFE DATES: From: 1977-12-29 To: 1978-02-13
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Backs of animals (Intact and Abraded skin sites)
- % coverage: Test site covered with 8 ply gauze
- Type of wrap if used: Saran wrap and elastoplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test areas were wiped with a wet paper towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (2 mL/kg)
- Concentration (if solution): Undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw for each test substance
No. of animals per sex per dose:
3 male and 3 female animals for each test substance (3 animals - intact, 3 animals - abraded)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation - daily for 14 days post administration; Weighing - Initial and final
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: For both P0304 and P0305 (60% each)
Mortality:
No mortality was observed.
Clinical signs:
other: P0304 (NH4C12 -13AE3S/ Shell shop) – Erythema was observed on all animals on day 1 and persisted on 3 of 6 for the full 14 days. Edema was observed only on day 3 and only on 2 of 6 animals. Atonia was observed on all animals beginning on day 3. Eschar dev
Gross pathology:
Necropsy results for both groups (P0304 and P0305) were not remarkable.
Other findings:
- Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The dermal LD50 for both P0304 (60% active NH4C12 -13AE3S) and P0305 (60% active NH4C12 -13AE3S) is > 2000 mg/kg. Thus, for both test substances no classification is warranted.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No effects.
Clinical signs:
other: No systemic effects.
Gross pathology:
No effects.
Other findings:
Moderate to severe dermal irritations at the treatment site were observed following removal of the dressings. 24 h after dermal application of the test substance four male and three female animals showed inflammation of the treated skin. One male and two females showed no skin lesions.
48 h after application an induration of the skin lesions occured and 72 h after application a scab formation was noticed. The scab was fallen off 6 days later in male animals and 12 days later in female animals. On day 14 only one female animal showed residual scabs and a slightly scarred skin.
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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: WISTAR rats Crl: WI(Han)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 7-8 weeks, females: 11-12 weeks
- Weight at study initiation: males: 221 – 235 g, females: 212 – 229 g.
- Diet (ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0939)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10%
REMOVAL OF TEST SUBSTANCE
- Washing: The residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing. Thereafter, the animals were observed for clinical signs once daily. The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occured.
Mortality:
No mortality occured.
Clinical signs:
other: No clinical signs of toxicity occurred. Signs of dermal irritation were observed. Erythema grade 1 was observed on 10/10 animals on day 4 which was fully reversed on day 5 on all animals. Eschar formation was observed from day 4 to day 8 and desquamation
Gross pathology:
Upon gross pathology hernia (liver) into the diaphragm was observed in one female. This incidental finding is not considered to be treatment related.

Table 1: Absolute Body Weights in g and Body Weight Gain in %

Animal No. / Sex

Day 1

Day 8

Day 15

Day 1-15

21 / male

226 g

241 g

282 g

25 %

22 / male

231 g

250 g

292 g

26 %

23 / male

230 g

238 g

274 g

19 %

24 / male

221 g

236 g

270 g

22 %

25 / male

235 g

245 g

282 g

20 %

Mean ± SD

229 ± 5.3 g

242 ± 5.6 g

280 ± 8.5 g

22 ± 3.0 %

26 / female

213 g

215 g

220 g

3 %

27 / female

216 g

213 g

217 g

0 %

28 / female

212 g

205 g

216 g

2 %

29 / female

229 g

227 g

250 g

9 %

30 / female

217 g

223 g

234 g

8 %

Mean ± SD

217 ± 6.8 g

217 ± 8.6 g

227 ± 14.6 g

4 ± 3.9 %
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:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Occlusive dressing.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No effects.
Clinical signs:
other: No systemic effects.
Gross pathology:
No effects.
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
Value:
2 000 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Additional information

The acute toxicity of AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) has been extensively evaluated in numerous oral and dermal toxicity studies. Additionally read across from structurally related AES, i.e. AES (C12-14, 1-2.5 EO) TIPA (CAS 174450-50-1), AES (C10-16) Na (CAS 68585-34-2) and AES (C8-10, 1-2.5 EO) Na was performed. The AES reported within the AES category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read across approach between structurally related AES. For details please refer to the category justification attached in IUCLID section 13.

The oral LD50 values based on the test material were all at least above 2 g/kg and the same result was achieved for the dermal route when tested.

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

In summary, no classification is warranted for either route of acute toxicity.

The following information is taken into account for any hazard / risk assessment:

Many high quality studies investigating the acute toxicity of alcohol ethoxysulfates (AESs) have shown that in terms of acute toxicity the use of these compounds are of low concern. They are of low oral and dermal toxicity.

 

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.

Justification for classification or non-classification

The available data on acute toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.