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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: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EC directive 92/69, method B.4.
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: 7-AMCA
Chemical name: (6R, 7R)-7-Amino-3-methoxymethyl-ceph-3-em-4-carbonic acid
CAS No.: 24701-69-7
Supplier: Sponsor
Batch No.: 8701633
Purity: 96.6 % (content related to water free substance)
Water content: 0.3 %
Appearance: white powder
pH: 3.95 of a 1 % aqueous suspension
Conditions of storage: Refrigerator, in the dark
Stability: Stable under conditions of storage

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Supplier: Charles River Wiga GmbH, D-97633 Sulzfeld.
Number and sex: 3 females.
Body weight (at the start and at the conclusion of the test): 2.4 to 2.7 kg, respectively 2.4 to 2.9 kg
Animal maintenance:
Hygiene: improved conventional conditions.
Room temperature: average of 19.5 °C.
Relative humidity: average of 50 %.
Air exchange: 12 per hour.
Light: artificial light from 6 a.m. to 6 p.m.
Cages: individual caging in metal wire cages.
Feed: Altromin 2023 diet for rabbits, ad libitum.
Water: tap water from an automatic watering system, ad libitum.
Acclimatization: 6 days.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg, soaked with 1.5 mL distilled water.
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h after patch removal.
Number of animals:
3
Details on study design:
Hair was clipped on the dorsal area of the trunk one day before the application of the test substance. An electric hair clipper with a 1 mm cutterhead was used. The test site was median on the dorsal thoracal region.
A cellulose patch with 0.5 g of the test substance (actual concentrations: 496, 504 and 498 mg), spread over an area of approximately 6 cm2 and soaked with 1.5 ml distilled water, was applied to the test site and held in place by fixing marginally with non irritating tape. The application site was covered by a dressing. Access by the animal to the application site was prevented by a plastic collar.
The duration of exposure was 4 hours.
At the end of the exposure period the dressing, the tape with the patch and the collar were removed. Residual test substance was wiped off using wet cellulose tissue.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible until 48 h p.a.
Other effects:
No other local or general findings were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not classified as irritant.
Executive summary:

The test substance was applied to the intact skin of each of 3 rabbits. The animals were examined for local reactions and for general signs. Methods and investigations were performed according to the OECD Guideline 404 and the EC method B.4.

Only slight erythema were observed in one rabbit at 1 and 24 h p.a. The test substance is not classified as irritant.