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Administrative data

Description of key information

No signs of skin irritation were observed in two Draize tests in rabbits (one reliable RL2, the other less reliable, RL3), supported by the absence of irritating effects in a reliable LLNA with mice.
The test substance was not irritating to the eyes in two reliable studies (RL1).

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:
other: Standard protocol with some deficiencies in data reporting
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
Skin irritation test according to Draize
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
no details
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0,5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
Exposure period 24 h in this study, compared to 4 h in OECD guideline 404
Use of impervious wrap
SCORING SYSTEM:
Evaluation of results according to ETAD score system: Values for erythema and edema (maximal score: 4 each) for intact and abraded skin at 24 and 72 h are added and divided by 4 to give the primary irritation score:
0 - 0.5:       non irritant
0.6 - 3.0:    slightly irritant
3.1 - 5.0:     moderately irritant
5.1 - 8.0:    severely irritant
Irritation parameter:
overall irritation score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed on intact skin
Remarks on result:
other: Based on the evaluation scheme of guideline OECD 404, the effects on intact skin would indicate an irritation score of 0 (based on restricted observations at 24 and 72 h only)
Irritation parameter:
overall irritation score
Remarks:
intact and abraded skin
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
8
Reversibility:
other: edema of grade 1 observed in all animals after 72 h on abraded skin
Remarks on result:
other: ETAD score
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance was not irritating to skin
Executive summary:

The test substance was applied to the skin of 6 albino rabbits for 24 h under an occlusive wrap. Skin reaction were evaluated at the end of exposure (time point 24 h) and 48 h thereafter (time point 72 h) according to the ETAD classification system. No skin irritation was observed in this study.

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:
From 21 April 1989 to 28 April 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.4-2.7 kg
- Housing: individually in stainless steel cages
- Diet (ad libitum): Kliba 341, Batch 44/89 rabbit maintenance diet, Klingentalmühle, Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as internal control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
up to 72 h
Observation period (in vivo):
up to 72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM:
according to OECD 405 and EU B.5

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects observed at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time point
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test substance was not irritating to the eyes of rabbits.
Executive summary:

The test substance was subject to an eye irritation test according to guidelines OECD 405 and EU B.5. 0,1 mL of the test item were instilled into the eyes of 3 rabbits and irritating effects were evaluated up to 72 h after application. The untreated eyes servaed as internal controls. No effects were observed. Under the conditions of the study the test substance was not irritating to the eyes of rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Two Draize tests with respect to irritation to rabbit skin are available. The submission substance was applied in two different forms: “active substance” was tested in a reliable study (RL2), “dispersion” in a less reliable study (RL3). No signs of irritation were observed on intact skin in both of the studies. The results could be evaluated according to OECD guideline, resulting in a score of 0 at any time point.

Supporting information can be drawn from a reliable (RL1) LLNA with mice (chapter 7.4.1), where no signs of skin irritation were evident.

Eye irritation

Two eye irritation studies are available, both according to guideline (RL1). The submission substance was applied in two different forms. In both studies there were no signs of irritation at any time point.


Justification for selection of skin irritation / corrosion endpoint:
Study equivalent to current guideline.

Justification for selection of eye irritation endpoint:
Two studies of identical quality with two different test items of the same submission substance are available

Justification for classification or non-classification

No evidence for skin irritation is emerging from a reliable Draize test, and the findings are supported by a less reliable study and a reliable LLNA. Therefore, the test substance has not to be classified for skin irritation according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.

Based on the absence of eye irritation in reliable studies, the test substance has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.