Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: HsdCpb: Wu
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Type of coverage:
other: semiocclusive, but predominantly covered with air-tight plaster
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TREATMENT
Test substance was applied ground by mortar on a wet gauze layer.
Treatment area: 30 cm²
TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10% of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry.
Duration of exposure:
24 hours
Doses:
limit dose of 2000 mg/kg bw ; according to 19.3 to 19.7 mg/cm² for male rats and 15.6 to 16.8 mg/cm² for female rats.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
Statistics:
none; limit dose test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: signs of local irritation. partial reddening, indurations, encrustation and formation of scale at the treatment area
Mortality:
No mortalities occured.
Clinical signs:
Partial reddening of the skin, indurations, encrustation and formation of scale at the treatment area in all animals.
Body weight:
There were no toxicologically significant effects on body weight or body weight development in males and females.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Interpretation of results:
other: low toxicity
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
2-Acetone polymer with phenol (BPA-Tars) is not acutely toxic to the rat via the dermal route of exposure up to a highr dose level of 2000 mg/kg of body weight. No Classification and Labelling based on acute toxicity is required.
Executive summary:

An acute dermal toxicity study was performed on rats according to OECD TG 402. For the purpose of a limit test 2000 mg/kg bw of the test item BPA-Tars were applied to the skin of 5 male and 5 female rats for 24 hours. Clinical signs were confined to signs of local irritation, as partial reddening of the skin, indurations, encrustation and formation of scale at the treatment area of all animals. The resulting LD50 was determined with > 2000 mg/kg bw for both sexes.