Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 18, 1976 - December 29, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
The sample was dosed as supplied.

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino Rabbits
Sex:
male/female
Details on test animals and environmental conditions:
N/A

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
All animals had their backs clipped free of hair 24 hours prior to testing . One half of the animals had their backs abraded prior to dosing.

All rabbits were weighed and the correct amount of experimental material was applied to the back of each animal. Treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.
The dressings were removed after twenty-four hours. Excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies were performed
on a ll animals that died during the 14 day observation period.
Duration of exposure:
24 hours
Doses:
All animals were dosed at 2.0 g/kg (2000 mg/kg)
No. of animals per sex per dose:
5 male and 5 female animals in one dose group (2000 mg/kg)
Control animals:
no
Details on study design:
One group of ten albino rabbits (5 male and 5 female) weighing between 2.5 and 3.5 kg. each were employed in this study.
After the dosing period, the occlusion was removed and the animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies would be performed on any animals that died during the 14 day observation period.
Statistics:
N/A

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortaities were observed
Clinical signs:
No unusual clinical or behavioral signs were noted.
Body weight:
Males mean initial weight 2.7 g, Mean Final weight 3.6 gm
Femaes mean initial weight 2.4 g, Mean Final weight 2.9 gm
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, TMR-2 was found to have an acute dermal LD50 greater than 2.0 gm/kg ((2000 mg/kg)