Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted under OECD guidelines, OECD Good Laboratory Practices

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Details on test material:
- purity: 99.75 %

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
-General information: Three male animals approximately 5-10 months of age with initial body weights of 2.4-2.6 kg were used.
-Diet: Ad libitum before and after the exposure period. Standard rabbit diet of Altromin 2023 (ALTROMIN GmbH, D-32791 Lage/Lippe). Food was analysed at least twice per year for contaminants.
-Drinking water: Water was offered ad libitum before and after the exposure period. Water samples were analysed twice per year for contaminants and once per year for a bacteriological investigation.
-Housing: Before and after the exposure period, animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schonwalde). During the exposure period, animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrement and urine.
-Acclimation period: At least 20 days.

ENVIRONMENTAL CONDITIONS
-Temperature: 17-23 degrees C
-Humidity: 30-70%
-Photoperiod: 12 hours light (150 lux at approximately 1.5 meter room height)/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg BPA per animal. 4000 mg of the test compound was mixed with 2 ml water and 750 mg of this paste was applied per animal.
Duration of treatment / exposure:
Four hours.
Observation period:
72 hours.
Number of animals:
Three male animals.
Details on study design:
Three male Himalayan rabbits were shaved on the dorsal trunk area. Only animals with healthy, intact skin were used. Approximately 24 hours after shaving, a dose of 500 mg BPA per animal was applied to the test site (approximate area of 6 square cm) and covered with a gauze patch that was held in place with non-irritating tape for the duration of the exposure period. The surrounding untreated skin served as a control. The exposure time was four hours. After exposure, the patch was removed and the scores of the resulting reactions were taken 60 minutes, 24, 48, and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritant / corrosive response data:
No substance-related lesions were observed at any time point. All animals had skin irritation scores of zero at all time points for both erythema and edema.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Conclusions:
The authors concluded that there were no substance-related lesions from the acute skin irritation test with BPA.
Executive summary:

Three male Himalayan rabbits were shaved in the dorsal trunk area and 24 hours later, 500 mg BPA per animal was applied to the test site. The surrounding untreated skin served as a control. The exposure period was four hours, after which the patch was removed and the resulting reactions were examined and scored at 60 minutes, 24, 48, and 72 hours after patch removal. The skin irritation scores for each animal were zero for erythema and edema at all time points. The authors concluded that there were no BPA-related lesions at any time point and there were no systemic intolerance reactions.