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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
2 animals per dose levels
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: Thioglycolic acid
CAS no.: 68-11-1
Source: Evans Chemetics Inc.
Batch: ba-93B-109
Purity: 98.2%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Twenty-four hours prior to applying the test materials, the entire trunk  of the rabbits to be used were clipped free of hair with electric  clippers. The test materials were applied under a heavy gauge plastic  cuff. The cuff was held in place with rubber bands and covered with a  cloth bandage which was taped securely to the marginal hair. Thioglycolic  acid was applied as a solution in water.
Duration of exposure:
24 hours
Doses:
252, 500, 1000 or 2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
After application of the test material, the animals were placed in  individual holding cages with free access to food and water. At the end  of the 24-hour exposure period, the cuffs were removed and the skin was  washed with soap and water, rinsed thoroughly, and dried with a towel.  The animals were observed for signs of toxicity during the exposure and  periodically for two weeks or more thereafter. Body weights were recorded  before and after the exposure period and at intervals up to two-weeks  post-application or until the pre-exposure body weights were surpassed.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
848 mg/kg bw
Based on:
test mat.
95% CL:
505 - 1 430
Mortality:
Dose        # dead/# treated        Time of Death 
250         0/4                        --- 
500         1/4                        Day 1
1000         2/4                         Day 1, 1
2000         4/4                        Day 1, 1, 1, 1
Clinical signs:
Topical effects noted after removal of the cuff were slight to moderate  erythema, slight to moderate oedema and slight to moderate necrosis in  all cases (no other clinical signs were reported). 
Body weight:
Surviving animals had body weights which surpassed their pre-exposure weight at the end of the  two-week observation-period.
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Executive summary:

In a non-guideline acute dermal toxicity study, 4 groups of 2 New Zealand whiterabbits per sex were dosed with 250, 500, 1000 or 2000 mg/kg bw thioglycolic acid (purity 98.2%). Animals were observed for 14 days following the exposure for mortality and clinical signs. Mortality was 0/4, 1/4, 2/4 and 4/4 on day one. No other effects than a skin irritation at the site of application was reported. The LD50was 848 mg/kg bw.