Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 to 23 November 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
EC Number:
603-094-7
Cas Number:
125904-11-2
Molecular formula:
C8 H6 Br2
IUPAC Name:
Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clerco Reasearch Farms, Cinicinnati, Ohio
- Age at study initiation: youg adults
- Weight at study initiation: 1.85 to 2.55 kg
- Housing: individually in steel wire-bottomed cages suspended above cage board that was changed three times a week.
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): checked daily
- Humidity (%): checked daily
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: 10 To: 23 November 1982

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hrs before treatment the back of the rabbits were clipped free of hair with an Oster small animal clipper. Individual dose amounts were calculated using day 0 body weights taken prior to dosing and considering specific gravity of the test substance of 1.83 g. Just prior to the application of the test material the skin test site of each animal was abraded by making a series of parallel epidermal abrasions, every 2 or 3 cm longitudinally with a 25-gauge hypodermic needle. These abrasions were made sufficiently deep to penetrate the stratum corneum but not to disturb the derma or produce bleeding. The required dose amount of liquid was measured in a disposable sterile syringe and applied to the test site. A glass stirring rod was used to distribute the test material evenly over the exposure site (approx. 240 cm2). Each test site was immediately occluded with a layer of 4-ply gauze, two single layersthick. The trunk of the rabbit was wrapped with rubber latex dental dam and the denatl dam taped at the edges with 1 inch Micropore tape to form an airtight occlusive wrap. The test material remained in contact for 24 hours. At the end of this period the dressing were removed and the residual test material gently wiped off with a paper towel.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
None needed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No signs of systemic toxicity were noted. Evaluation of local skin reactions revealed severe to slight erythema and oedema (10/10), mild to slight scaling (10/10), abraded lines well defined (2/10), atonia (1/10), haemorrhaged area (2/10) and compound residues (10/10).
Body weight:
Individual and mean body weights increased at each recoding time following dosing.
Gross pathology:
No abnormality was detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of dibromostyrene was greater than 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study, 5 male and 5 female New Zealand rabbits received a single dermal application of dibromostyrene at 2000 mg/kg bw under occlusive conditions. Exposure lasted 24 hours. Animals were observed for 14 days following treatment.

No mortality occurred during the study. Only skin reactions but no systemic clinical signs were noted. All animals gained weight during the study.

The acute dermal LD50 was greater than 2000 mg/kg bw.