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Administrative data

Description of key information

The test substance is not irritating to skin and eyes when tested in 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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
prior to GLP
Species:
rabbit
Strain:
other: White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Age at study initiation: not specified
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 55 +/-5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/14
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5g
For treatment gauze patches of 2.5 x 2.5 cm soaked with the test substance were applied to the prepared abraded and non abraded skin.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: flank and back, 2.5 x 2.5 cm
- Type of wrap if used: adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize system
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
other: 24 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
other: 24 h, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The primary skin irritation index in this experiment was established to be 0.
Interpretation of results:
GHS criteria not met
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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific pronciples, acceptable for assessment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
prior to GLP
Species:
rabbit
Strain:
other: White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 55 +/-5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/14
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

VEHICLE
- Amount applied: not applicable
Duration of treatment / exposure:
Once, the test substance was inserted into the conjunctival sac of the left eye each and the lids were gently held open for one second.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes (animal 1-3) / no (animal 4-6)
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The potential of the test substance to cause acute dermal irritation or corrosion was investigated in a patch test equivalent or similar to OECD TG 404, although the exposure parameters were more stringent (24 h exposure, occlusive conditions). The test article was applied to both intact and abraded skin of 3 male and 3 female rabbits. Observation was terminated after 72 hours which is acceptable as no indication of erythema or erythema was observed during the observation period. All scores for edema and erythema were zero at any time point. Based on the results of this study, the test article is considered to be not irritating to the rabbit skin.

Eye irritation

An eye irritation test was performed with three female and three male rabbits from the Russian breed similar to OECD 405. The eyes of three rabbits were left unwashed after application of 0.1 g unchanged test substance and the animals were observed 7 days. The eyes were examined at 24, 48, 72 hours, then 4 days and 1 week after the application. There was no evidence of conjunctivitis, iritis, and corneal inflammation with the test substance, all scores were 0 for all time points.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the test substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008.

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