Registration Dossier

Administrative data

Description of key information

Studies of skin and eye irritation are available in the rabbit with the submission substance

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:
19 December, 1978 - 31 January, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity, the quantity of test suibstance applied if a patch was used, the surface of the patch, how the patch was kept in contact with the skin)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males2390 - 2586 g, females 2190 - 2570 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 08/02/1979 To:11/02/1979
Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
other: wetted with 0.9% saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): wetted with 0.9% saline
- Purity: no data
Duration of treatment / exposure:
72 hours
Observation period:
72 hours
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

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

SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.04
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No further data
Other effects:
No further data

No further data

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did cause irritation or corrosion to the skin and therefore is not classified for skin irritation/corrosion according to EU criteria
Executive summary:

In a study conducted in 1979, the test substance Busan 11-M1was examined for its ability to cause skin irritation when tested on intact and abraded rabbit skin. The exposure sites on each animal were shaved and then two sites were left intact and two sites were abraded prior to exposure. The test substance wetted with saline was applied under a gauze pad to the sites. The skin reactions of each test animal were observed for 72 hours. Slight erythema with developed which was fully reversible and was not accompanied by any other irritation reactions. Under the conditions of this study, the test substance Busan 11-M1was considered not to be irritating to intact or abraded rabbit skin. Based on these results, the test substance does not warrant classification for skin irritation in accordance with Regulation EC No. 1272/2008.

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:
weight of evidence
Study period:
12 December, 1978 - 4 January, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The quantiy of test material instilled in the sac of the eyes is not known. The study should have been carried out beyond 7 days to show reversibility in the animal that showed corneal opacity. Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature, humidity, how the test substance is instilled etc...).
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation was tested in 3 rabbits. Test substance was instilled into the eyes of the rabbits. The eyes were then washed for 1 minute with lukewarm water 30 seconds after instillation of the test material. The rabbits were observed for 72 hours. Corneal opacity and area, iris, and conjunctivae redness, chemosis and discharge were scored at the 24 hour, 48 hour, 72 hour and 7 day time points.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males 2610 - 3058 g, female 3618 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 88/12/1979 To: 04/01/1979
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 (2 male and 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were then washed for 1 minute with lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas

TOOL USED TO ASSESS SCORE: No data
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.55
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: A further timepoint may have established reversibility
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No further data
Other effects:
No further data

No further data

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material caused mild and transient irritation to the eyes which is expected to be fully reversible and therefore is not classified for eye irritation/corrosion.
Executive summary:

In a study conducted in 1979, the potential of the test substance Busan 11-M1to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation.  Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion

In a study conducted in 1979, the test substance Busan 11-M1 was examined for its ability to cause skin irritation when tested on intact and abraded rabbit skin. The exposure sites on each animal were shaved and then two sites were left intact and two sites were abraded prior to exposure. The test substance wetted with 0.95 saline was applied under a gauze pad to the sites. The skin reactions of each test animal were observed for 72 hours. Slight erythema with developed which was fully reversible and was not accompanied by any other irritation reactions. Under the conditions of this study, the test substance Busan 11-M1was considered not to be irritating to intact or abraded rabbit skin. Based on these results, the test substance does not warrant classification for skin irritation in accordance with Regulation EC No. 1272/2008.

Eye Irritation/Corrosion

In a study conducted in 1979, the potential of the test substance Busan 11-M1 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation.  Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.

In a further study conducted in 1979, the potential of the test substance Busan 11-M1 to cause irritation to the eyes was determined in rabbits. Six New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. The test animals were observed for 7 days after instillation.  Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, all reactions had resolved by 7 days after instillation. Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.


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

Justification for selection of eye irritation endpoint:
A weight of evidence approach if followed for this endpoint.

Justification for classification or non-classification

The test material did cause significant irritation or corrosion to the skin or eyes and therefore is not classified for skin or eye irritation/corrosion according to the CLP Regulation.