Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
purity of the test substance not specified

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: C-001 388
- Trimethylolpropane tris (3-azirinyl) propanoate (CAS# 52234-82-9); (Paradox ID:A-11/08/91:01101)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- Type of wrap if used: The application site was covered with gauze pads and the entire torso was overwrapped with rubber dam.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: Twenty-four hours later, the wraps and excess material were removed.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
Duration of exposure:
24 hours
Doses:
2 g/kg
No. of animals per sex per dose:
6 (The backs of three of the rabbits had intact: skin; the others had epidermal abrasions every 2 or 3 cm longitudinally over the area of exposure.)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily; body weights were determined initially and then weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
- One of the three rabbits in the intact skin group died 8 days after application
Clinical signs:
- back of each rabbit was severely rugose, dessicated, edematose (Draize Grade 4), and erythematous (Draize Grade 4), and focal exudation was apparent (not altered by washing the excess compound from the back)
- the damaged skin began to slough off (skin underneath was extremely tender) 6 days after application, but no rabbit had returned to normal by day 14
Body weight:
- rabbit that died on day 8 showed a body weight decrease of 33 %
Gross pathology:
no effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal (LD50) study in the rabbit showed that the LD50 of the test substance is greater than 2 g/kg on both intact and abraded skin.