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Toxicological information

Acute Toxicity: oral

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Administrative data

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: Comparable to Guideline study. Limited information concerning test conditions, dose levels as well as experimental methods and results.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium laurylsulfate
- Physical state: white powder
- Analytical purity: >98% a.i.
- Lot / Batch No. : 68/3
- Storage condition of test material: No data

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levelsopen allclose all
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.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Acute Tox. 4, H302
DSD: Xn, R22
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 (Potokar, 1983). Both sexes were dosed with the test substance diluted in water at ascending dose levels via gavage. Mortalities occurred but no details were available. 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.