Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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:

Sex: Females, nulliparous and non-pregnant
Acclimatisation period: At least 10 days
Age and weight range: 9 to 11 weeks old, approximately 2 kg
Housing: Polycarbonate/stainless steel cages measuring 65.3x65.3x45 cm with perforated NorylTM floor suspended over trays
Water supply: ad libitum
Diet: STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK
Diet supply: ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature range: 19°C ± 2°C
Relative humidity range: 55% ± 15%

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Controls:
no
Amount / concentration applied:
Dose calculation: 0.5 mL for each animal
Treatment area preparation: On the day before dosing. A single area was clipped free of hair (by electric clipper equipped with a suitable blade) on both sides of the mid-line of the dorsal surfaces of the trunk of each animal (approximately 15 cm long by 10 cm wide). Care was taken to avoid damage to the skin.
Dosing procedure: An aliquot of the supplied test item was spread evenly over a square gauze measuring 25 x 25 mm. 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, this forming a semi-occlusive barrier.
Duration of treatment / exposure:

Exposure time : 4 hours
Observation period:

Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.
Additional examination: Day 8
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Irritation
No erythema or oedema was noted at the observation performed approximately 1 hour after dosing. Very slight erythema (score of 1) was observed in all treated animals during the 24 hour observation. One animal recovered at 48 hour examination, whereas for 2/3 animals recovery occurred by Day 8 of the study.
Other effects:
Systemic effects and clinical signs: There was no indication of a systemic effect and no clinical signs were observed.

Body weight: Changes in body weight, seen during the course of the study, were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required