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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:
From January 27 to February 01, 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The batch tested is a commercial product

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
April 2002
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy; Breeder: Harlan France S.a.r.l., F-03800 Gannat, France
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 1.74 to 2.01 kilograms
- Housing: grid-bottomed metal cages suspended over trays measuring 45x51x69 cm (during study) or 48x41x63 cm (during acclimatisation)
- Diet (e.g. ad libitum): STANRAB (P) SQC (Special Diets Services, Witham, Essex CM8 3AD, UK) ad libitum throughout the study
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: At least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 25 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of
12/12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after application of the test item
Number of animals:
3 (1 for the preliminary and two additional animals for the full test)
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage:
- Type of wrap if used: square gauze measuring 2.5x2.5 cm. The square gauze was then placed onto the animal’s skin with the test item in direct contact with the skin. A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: immediately after exposure

OBSERVATION TIME POINTS
Mortality and morbidity : Twice daily
Body weight : Allocation (Day-1), on termination (Day 4)
Observations : At allocation; approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.

SCORING SYSTEM: Erythema and eschar formation Value
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation 4
preventing grading of erythema

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin irritant
Executive summary:

Method

The acute dermal irritation of the test item was investigated in the rabbit, according to the OECD guideline 404.

A 0.5 ml aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed approximately 1, 24, 48 and 72 hours after the end of the exposure period.

Observations

No erythema or oedema was apparent following a 4 hour period of exposure to the test item in any animal of the study.

There was no indication of a systemic effect of treatment. Body weight changes were not remarkable.

Conclusions

These results indicate that the test substance has no irritant effect on the skin of the rabbit.