Registration Dossier

Administrative data

Description of key information

No irritation effects were recorded after occlusive exposure of skin (intact as well as scarified)
Only slight irritation effects were recorded after exposure of eyes to the dry powder (mechanical irritation by solid grains)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study short report, but giving the main details of design and performance, intensified conditions with still not irritant result
Reference:
Composition 1
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
extented exposure, add. scarified skin
GLP compliance:
no
Remarks:
pre dates GLP regulation
Test material information:
Composition 1
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
SPF-Albino-Himalayan-Kaninchen
Strain: Hoe:HIMK(SPFWiga)

- Weight at study initiation: 1,5-2 kg
- Housing: single
- Diet (e.g. ): ad libitum
- Water (e.g. ad libitum): ad libitum
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg/ site
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: surgical gauze + occlusive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 h

SCORING SYSTEM:
§ 1500.41 Federal Register 38, No. 187, 27. 9. 1973, p 27019
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered not irritant.
Executive summary:

The fur of 6 rabbits (weight; 1,5 to 2,0 kg) was clipped free of hair with aa electrical clipper at two adjacent sites (each 3 x 3 em)

One of the two sites was sacrified additionally.

Pieces fot surgigal gauze (2,5 x 2.5 cm²) loaded with 500 mg of the powder were fixed using adhesive tape to the application sites. Sites were covered occlusively with 6 -8 cm wide PVC foiles fixed to the trunk with an elastic bandage.

Exposure lasted for 24 hours. Immediately afterwards observations were made and repeated 48 and 72 hours after the start of exposure.

Based on the findings the irritation index was calculated according to § 1500.41 Federal Register 38, No. 187, 27. 9. 1973, p 27019, Result: Der test item was tolerates by all animals without any effect (Index = 0) and is therefore considered not irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, short report but giving all major details, no GLP
Reference:
Composition 1
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: Federal Register Vol. 38, Nr. 187, S. 27019, 1973
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test material information:
Composition 1
Species:
rabbit
Strain:
Himalayan
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 0.9% saline
- 24 hours after application


SCORING SYSTEM: Federal Register Vol. 38, Nr. 187, S. 27019, 1973
"Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 h
Score:
12
Max. score:
12
Irritant / corrosive response data:
The slight, transient effects recorded in this study cause by application of the dry powder were considered as mechanical irritation by solid grains of the test material.
Other effects:
no data
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975
Conclusions:
The test item was found to be sligthly irritant to eyes (powder effect)
Executive summary:

Six rabbits were emploeyed to determine the effects of the test item on the mucous membranes of the eye. 100 mg try powder were applied per eye to the conjunctival sac. The left eye was treated the right served as control. The test war performed according to Federal Register Vol. 38, Nr. 187, S. 27019, 1973.

Observations ere recorded 1, 7, 24, 48 and 72 hours after application using a magnifying lens. After observation at 24 hours all eyes were washed using saline. Observations at 48 and 72 hours were made after instillation of sodium fluorescin solution (0.01%).

Effects wwere scored according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, S. 51, 1975.

Result:

After application of the dry powder the maximum irritation index of 12 was observed after 7 hours.

The slight, transient effects recorded in this study cause by application of the try powder were considered as mechanical irritation by solid grains of the test material.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No irritation effects were recorded after occlusive exposure of skin (intact as well as scarified) Only slight irritation effects were recorded after exposure of eyes to the dry powder (mechanical irritation by solid grains)


Justification for selection of skin irritation / corrosion endpoint:
only available study

Justification for selection of eye irritation endpoint:
only available study

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

no classification

no effects werer recorded after dermal exposure. After exposure of eyes only slight effects weres seen which were considered as mechanical irritation by the try powder