Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
1997/10/08-1997/10/19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD test guideline 404. GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

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: Elevage Cunicole de Val de Selle
Number of Animals: Three males
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.6 +/-0.1 kg
Housing: Individually
Diet (e.g. ad libitum): 112 C pelleted diet
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 8d

ENVIRONMENTAL CONDITIONS
Temperature (°C): 15-21
Humidity (%): 30 to 70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
Observation period:
24, 48, and 72h post application and once per day until Day 14
Number of animals:
Three males
Details on study design:
SCORING SYSTEM: Draize scale for dermal irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 Hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.53
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. 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
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
A very slight or well-defined erythema was observed in all animals from day 1 up to day 9 or 10. A slight oedema was noted in two animals on day 1 only. Dryness of the skin was recorded in all animals from day 4or 5 up to day 1 or 11. Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of ECOLANE 90 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring.  A very slight or well-defined erythema was observed in all animals from day 1 up to day 9 or 10. A slight oedema was noted in two animals on day 1 only. Dryness of the skin was recorded in all animals from day 4 or 5 up to day l or 11.  Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.  Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.