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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
Study period:
5th March 1993 to 16th June 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline studies with restrictions. Information relating to the test animals, exposure and test system were not described in the main body of the report but were given in the protocol only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity 97.3%
Batch No.: 9236-23

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS (information provided in study protocol)
- Source: E.S.D, Romans, 01400, Chatillon-sur-Chalaronne, FRANCE
- Age at study initiation: adult (about 3 months old)
- Weight at study initiation: 2.00 to 3.00 kg
- Housing: Animals individually housed in stainless steel cages (internal dimensions 500 x 600 x 400 mm).
- Diet (e.g. ad libitum): About 150 g/animal/day of pelleted complete rabbit diet (Diet reference 112 C - Usine d'Alimentation Rationnelle, Villemaisson, 91360 Epinay-sur-Orge, FRANCE).
- Water (e.g. ad libitum): Softened and filtered mains drinking water available ad libitum (via automatic system).
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS (information provided in study protocol)
- Temperature (°C): 19 ± 3 °C
- Humidity (%): minimum35%
- Air changes (per hr): minimum 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)I12 hours dark

IN-LIFE DATES: Not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Sterile Codex liquid paraffin
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.46 g
- Batch no. (if required): T 8810 B
- Purity: Not specified
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
6 animals
Details on study design:
TEST SITE (information provided in study protocol)
- Area of exposure: The test material is applied to the animal's skin, to an area about 6 cm2 and then covered with a Codex hydrophilic eight layer gauze pad, of the same surface.
- % coverage: Not specified
- Type of wrap if used: The test article will be applied under a semi-occlusive dressing composed of a gauze pad approximately 2.5 cm x 2.5 cm, maintained in contact with the skin with a perforated tape. This tape will be applied on a crimped gauze bandage which will fully cover the clipped area to avoid possible imitation reactions and be wrapped around the animal without blocking the respiratory and abdominal movements.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The bandages were removed and, if necessary, excess test article which had not penetrated was wiped away with a gauze pad moistened with pure plive oil. Readings were then carried out 1 hour later.
- Time after start of exposure: 4 h

SCORING SYSTEM: As specified in OECD Guideline 404 (1981)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
1.17
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0.67
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
other: Mean overall score for 24, 48 and 72 h.
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Remarks:
Mean overall score for 24, 48 and 72 h
Irritation parameter:
edema score
Basis:
animal: All
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
other: Mean overall score for 24, 48 and 72 h.
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Remarks:
Mean overall score for 24, 48 and 72 h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
From the results obtained under the experimental conditions employed, application of the test article to the rabbit skin provoked a weak irritation but the effects were fully reversible by 72 hours after treatment.
Executive summary:

The test material, Millad®3988, was evaluated for its acute primary cutaneous irritation and corrosivity potential in male rabbits. The results obtained under the experimental conditions employed demonstrated that application of this test article to the rabbit skin provoked a weak irritation (erythema) but the effects were fully reversible by 72 hours after treatment. No oedema was observed over the 72 hour post exposure period.