2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)

EC Number:

257-765-0

EC Name:

2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)

Cas Number:

52234-82-9

Molecular formula:

C21H35N3O6

IUPAC Name:

6-(aziridin-1-yl)-2-({[3-(aziridin-1-yl)propanoyl]oxy}methyl)-2-ethyl-4-oxohexyl 3-(aziridin-1-yl)propanoate

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 or test system 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:

other: - 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

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.