Registration Dossier

Administrative data

Description of key information

The test substance is not irritating to skin and eyes of rabbits.

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:
February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
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
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 5.5-8 months
- Weight at study initiation: 2.9-3.0 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: test item moistened with water
Controls:
other: the surrounding untreated skin served as control
Amount / concentration applied:
0.5 g/patch and animal
4000 mg of the test compound were mixed with 4 ml water, 1000 mg of this paste were applied per animal
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, the patch was held in contact with the skin by means of a semi-occlusive dressing (no further information available)

REMOVAL OF TEST SUBSTANCE
- Washing: the patch was removed and the skin sites were evaluated (no further information available)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to DRAIZE
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
No systemic intolerance reactions were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an acute skin irritation study according to OECD TG 404 the test substance was applied for 4 hours to the shaved skin of 3 male rabbits. No rabbit showed any substance-related lesions at the examination time-points 1, 24, 48 and 72 hours after patch removal. No systemic intolerance reactions were observed.

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:
February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 3 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single instillation of the test substance into the conjunctival sac; no rinsing of the eye at any time; 24 hours after administration the eyes were treated additionally with fluorescein and examined.
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
24 hrs fluorescein test: no pathological findings.
Other effects:
No systemic intolerance reactions were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an acute eye irritation study according to OECD TG 405 100 mg of test substance per animal was applied into the conjunctival sac of the right eye of 3 male rabbits. No rabbit showed any substance-related changes at the examination time-points 1, 24, 48 and 72 hours after the administration. The cornea, iris and conjunctivae were not affected by instillation of the test compound. No systemic intolerance reactions were observed.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In an acute skin irritation study according to OECD TG 404 the test substance was applied for 4 hours to the shaved skin of 3 male rabbits. No rabbit showed any substance-related lesions at the examination time-points 1, 24, 48 and 72 hours after patch removal. No systemic intolerance reactions were observed.

 

Eye irritation 

In an acute eye irritation study according to OECD TG 405 100 mg of test substance per animal was applied into the conjunctival sac of the right eye of 3 male rabbits. No rabbit showed any substance-related changes at the examination time-points 1, 24, 48 and 72 hours after the administration. The cornea, iris and conjunctivae were not affected by instillation of the test compound. No systemic intolerance reactions were observed.


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

Justification for selection of eye irritation endpoint:
Only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.