Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No experimental data are available for the target substance C16 IOS-Na.


 


An acute oral toxicity study according to OECD Test Guideline (TG) 401 is available for the closely related source substance 2 (C14-16 AOS-Na). In this study male and female animals (5 per group; 2000 mg/kg bw only 5 females) have been given a single oral dose of the test substance in water. The dose groups were 0 (control), 1600, 2500 or 4000 mg/kg bw. Mortality was seen in male animals starting from the lowest dose group and for females at and about 2000 mg/kg. Clinical signs of intoxication were non-specific e.g. lethargy, decreased motor activity and respiratory rate, diarrhea and, at necropsy, major findings were irritation of the gastrointestinal tract. The oral LD50 of source substance 2 (C14-16 AOS-Na) in rat was >2000 mg/kg bw and thus the test substance does not have to be classified for acute oral toxicity.


 


The result can be also applied for the target substance because the minor structural differences between the target substance and source substance 2 (see details above) are not expected to have an impact on acute oral toxicity. 


 


In an available review (Ter Haar, 1983a) the testing of 6 different samples of 36.9% Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts in male rats is described, and although documentation is limited, acceptable LD50 values, ranging from 3800 to 4500 mg/kg bw and referring to active ingredient, are reported, which are acceptable for assessment.

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
Study period:
01. November 1984 to 11. December 1984
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
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Hostapur OS Pulver; alpha-Olefinsulfonate, sodium salt
- Molecular weight (if other than submission substance): approx. 310
- Physical state: white powder
- Analytical purity: approx. 90 %
- Impurities (identity and concentrations): approx. 5 % Na2SO4, 3 % Na2CO3, 2 % residual oil
- Composition of test material, percentage of components: C-chainlengths: ≤ C12: max. 1 %, C14: approx. 65 %, C16: approx. 30 %, ≥ C18: max. 1.5 %
- Lot/batch No.: E0617179, dated 1984-06-05
- Storage condition of test material: dark at 22°C in fume hood
- Other: Source: Hoechst AG
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Weight at study initiation: males 180 - 205 g (mean 195.4 g); females 161 - 184 g (mean 168.7 g)
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: 5/cage
- Diet (e.g. ad libitum): rat diet Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 6.3, 8.0, 10.0, 16.0 ml/kg bw
- Justification for choice of vehicle: water, good solubility


MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg
Doses:
1600, 2000, 2500, 4000 mg/kg bw
No. of animals per sex per dose:
5 (2000 mg/kg bw only 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 10, 30 and 60 min, 2, 4 and 6 hours, and 1, 2, 3, 4 and 14 daysafter application, weighing was performed weekly (prior to dosing and on day 7 and 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, time to lethality
Statistics:
The LD50, 95 % confidence limits and the linear Probit equation were calculated from mortality rates by Probit analysis.
LD50 values were calculated separately for males and femalesas well as combined.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 290 mg/kg bw
Based on:
test mat.
95% CL:
> 1 820 - < 3 130
Sex:
male
Dose descriptor:
LD50
Effect level:
2 340 mg/kg bw
Based on:
test mat.
95% CL:
> 1 690 - < 3 270
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 310 mg/kg bw
Based on:
test mat.
95% CL:
> 1 990 - < 2 790
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 079 mg/kg bw
Based on:
act. ingr.
95% CL:
> 1 791 - < 2 511
Remarks on result:
other: recalculated to active ingredient
Mortality:
males:
1600 mg/kg bw: 1/5
2500 mg/kg bw: 2/5
4000 mg/kg bw: 5/5

females:
1600 mg/kg bw: 0/5
2000 mg/kg bw: 1/5
2500 mg/kg bw: 4/5
4000 mg/kg bw: 5/5
Clinical signs:
males and females: hunched posture, hollow flanks, lateral position, quiet behaviour, clonic convulsions (weak), negative startle reflex, ruffled fur, cyanosis, hypothermia, closure of palpebral fissure, mucous faeces, irregular and intermittent breathing. Two females temporarily demonstrated increased sensitivity towards touch, two males demonstrated an distended abdomen on day 1 and 2.
Body weight:
No reduction of body weight observed.
Gross pathology:
Macroscopic examination of the deceased animals demonstrated damages of the gastro-intestinal tract. The stomachs were tightly filled with brownish fluid and foam, respectively. The gastric mucosa showed a dark-red colour with sporadical hemorrhages. The mucosae of colon and small intestine showed a dark-red colour, as well, sporadically with hyaline appearance. Blood vessels of the GI-tract were injected.

The animals sacrificed at the end of the observation period did not show any macroscopic changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts in rats was > 2000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.
They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.

Therefore, read-across from the existing toxicity studies on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.1, 8.2, 8.3, 8.4, 8.5 as well as 9.1 and 9.2 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see cross reference to assessment report: Justification for read-across document attached to section 13

3. ANALOGUE APPROACH JUSTIFICATION
see cross reference to assessment report: Justification for read-across document attached to section 13

4. DATA MATRIX
see cross reference to assessment report: Justification for read-across document attached to section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Limit test:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
2 290 mg/kg bw
Based on:
test mat.
95% CL:
> 1 820 - < 3 130
Sex:
male
Dose descriptor:
LD50
Effect level:
2 340 mg/kg bw
Based on:
test mat.
95% CL:
> 1 690 - < 3 270
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 310 mg/kg bw
Based on:
test mat.
95% CL:
> 1 990 - < 2 790
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 079 mg/kg bw
Based on:
act. ingr.
95% CL:
> 1 791 - < 2 511
Remarks on result:
other: recalculated to active ingredient
Interpretation of results:
GHS criteria not met
Conclusions:
Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts does not have to be classified for acute oral toxicity because the LD50 is > 2000 mg/kg bw
Executive summary:

This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because


Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.


They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.


Therefore, read-across from the existing acute oral toxicity study on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.5.1 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
OECD guideline study, no deviations, GLP

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to GHS Regulation EC No 1272/2008, a classification for the substance is not required and labelling is not necessary.