Registration Dossier

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:
1989

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: see attached report
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Sample reference: NBW 8809/52)
- Physical state: red powder
- Moisture : <0.2 % water
- sample CTL refereence No: Y04203/002/001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr 01 dham, Greater Manchester, UK
- Weight at study initiation: 3492, 3370, 3395 and 3392g
- Housing: satinised aluminium sheet cages (60.5cm width x 49cm depth x 45.5cm height). Floor of each cage was made of perforated aluminium sheet and the door was made of polycarbonate (MAKROlON)
- Diet (e.g. ad libitum): free access to food (Labsure CRB Rabbit Diet)
- Water (e.g. ad libitum): unlimited access to water via an automatic system.
- Acclimation period: minimum of 6 days prior to the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 °C
- Humidity (%): 5O±1O%.
- Air changes (per hr): 20-30 air-changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light and 12 hours of darkness.

Test system

Preparation of test site:
clipped
Vehicle:
other: paste with olive oil (1.0 ml)
Amount / concentration applied:
The test sample (approximately 5OOmg) was moistened to a paste with a small amount (l.Oml) af olive oil and was then appl ied to the test site
(approximate size 2.5cm x 2.5cm)
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 1, 2 and 3 days after removal of the dressings.
Number of animals:
Four male rabbits
Details on study design:
The treated area was covered with a piece of surgical gauze (approximate size 2.5cm x 2.5cm; 8 ply) which was secured by two crossed strips of
surgical tape (approximate size 1.2cm x 8cm). This was covered by a piece of impermeable rubber sheeting (approximate size 35cm x l3cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5cm wide).

Results and discussion

Any other information on results incl. tables

After a single four-hour application of Substance it was not possible to assess the degree of erythema owing to red staining of the test site. Histopathological examination revealed slight inflammation of the skin (consisting of inflammatory cell infiltration and acanthosis) in two animals and moderate inflammation of the skin in the other animal.

Very slight or slight oedema was observed in all animals 30-60 minutes after decontamination. These signs regressed in two animals during the subsequent observation period. One animal showed signs of moderate oedema which persisted up to three days after decontamination.

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant)
Remarks:
Migrated information not Irritant in the EU
Conclusions:
In conclusions the tested Substance was a mild irritant following a single four-hour application to rabbit skin.
It is then not irritant in the EU.
Executive summary:

not irritant (EU)