Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
14 - 21 Dec 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS GmBH, Med. Versuchstierzuchten KG, D-7964 Kisslegg
- Age at study initiation: adult, age not specified
- Weight at study initiation: 2 to 3 Kg
- Housing: individually in metal cages
- Diet: standard rabbit food NAFAG, No. 814 Gossau SG, ad libitum
- Water: ad libitum.
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin.
Vehicle:
other: polyethylene glycol (PEG 400) + Saline (70:30)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of test material
- Application: gauze patches of 2.5 x 2.5 cm laden with the test material

VEHICLE
- Concentration: 50%
Duration of treatment / exposure:
The dressings were removed after a 24 hour application.
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure: before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland.
- Type of wrap if used: the patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM
Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.625
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Other effects:
One animal died after 6 days. No symptoms had been observed previously.

Any other information on results incl. tables

Intact skin reactions

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
144 Erythema 2 1 0 0 0 0.75
145 Erythema 2 1 1 1 0 1.25
146 Erythema 2 1 0 0 0 0.75
147 Erythema 1 1 1 0 / 0.75
148 Erythema 1 0 0 0 0 0.25
149 Erythema 0 0 0 0 0 0.00
144 Oedema 2 1 0 0 0 0.75
145 Oedema 1 1 0 0 0 0.50
146 Oedema 2 1 0 0 0 0.75
147 Oedema 0 0 0 0 / 0.00
148 Oedema 0 0 0 0 0 0.00
149 Oedema 0 0 0 0 0 0.00

Abraded skin reactions

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
144 Erythema 2 1 1 0 0 1.00
145 Erythema 2 2 1 1 0 1.50
146 Erythema 2 1 0 0 0 0.75
147 Erythema 2 2 1 1 / 1.50
148 Erythema 1 0 0 0 0 0.25
149 Erythema 1 0 0 0 0 0.25
144 Oedema 2 1 0 0 0 0.75
145 Oedema 1 0 0 0 0 0.25
146 Oedema 1 1 0 0 0 0.50
147 Oedema 2 1 1 1 / 1.25
148 Oedema 0 0 0 0 0 0.00
149 Oedema 0 0 0 0 0 0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

Method

The skin irritation potential was tested in New Zealand White rabbits. The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Results

Under the conditions of the present experiment the test compound was found to cause a slight irritation when applied to intact and abraded rabbit skin. One animal died after 6 days.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (1272/2008), because the raw tables are included into the study report. Only the intact skin reactions were considered.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).