Registration Dossier

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: U.S. 52 FR 42961, 49 CFR 173.132
Principles of method if other than guideline:
This study was performed under the DOT guidelines specified in 52 FR 42961, 49 CFR 173.132
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Yellowish Brown Liquid, Lot # 00312AB, no purity given

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Ten albino ratts (5 male and 5 female) were used in the study

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dorsums were clipped free of hair prior to application of the test article. The test article was introduced to not less than 10% of the total body surface area (15.5cm x 15.5cm) The test article was held in contact with the skin with prous gauze dressing and non-irritating tape. The animals were further wrapped with Vetrap bandaging for the exposure period.
Duration of exposure:
24 hours
Doses:
1000 mg (1 g)/kg bw, as specified by sponsor
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The duration of the occlusive exposure was 24 hours. At the end of the exposure period, the test sites were rinsed with water and the animals observed for signs of erythema and edema. The animals were then observed daily for clinical signs of toxicity for a 14 day observation period. At the end of the observation period, a gross necropsy was performed on all animals.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
The LD50 may be > 2000 mg/kg bw
Mortality:
None observed
Clinical signs:
No signs of toxicity were observed in any of the animals. However, erythema was noted on all animals after the 24h exposure period and was reversed on all animals by Day 5.
Body weight:
All animals gained weight during the course of the study.
Gross pathology:
No unusual observation recorded in gross pahtologies.

Any other information on results incl. tables

Erythema was noted on all animals after the 24h exposure period, but resolved in all animals by day 5.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of the test material is > 1000 mg/kg bw, with no observed lethality for 14 days after exposure. This was evaluated as "non-toxic" according to the U.S. DOT guidelines.