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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, 5-day observation period), analogy of test substance with registered substance not unequivocally assignable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(limited documentation, observation period 5 days, no data on exposure duration, no information on treatment)
Principles of method if other than guideline:
6 females rabbits were topically treated with different doses of the test substance and observed for mortality and clinical signs.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Analogy of test substance with registered substance not unequivocally assignable.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.3 kg (mean)

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data ("large area of body surface covered")
Duration of exposure:
no data
Doses:
1580, 2510, 3980, not legible, 10000 and 15800 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 0/6 animals died at the highest dose.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No symptoms of systemic toxicity were noted.
Body weight:
Body weight changes were -0.2 to +0.2 kg after 5 days.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

In an acute dermal toxicity study, 6 groups of 6 female rabbits were dermally exposed to doses ranging from 1580 to 15800 mg/kg bw of the unchanged test substance (no data on purity) for an undefined time period. Animals were then observed for at least 5 days. 

No mortalities occurred. The LD 50 thus lies higher than 15,800 mg/kg bw. No clinical signs of toxicity were observed up to the end of the observation period. There were no treatment related changes in body weight. Necropsy of surviving animals was not performed (TSCATS – Monsanto, 1963). 

This study does not fully satisfy the requirement of OECD 402 for Acute Dermal Toxicity data as duration and mode of treatment was not described and necropsy of surviving animals was not performed. In addition, there is limited data provided on test substance (e.g. there is no data on test substance purity). Nevertheless, the study is considered suitable for assessment as the key data is given.