Registration Dossier

Administrative data

Description of key information

Skin irritation: The skin irritation potential of the test substance was determined in a study equivalent to OECD guideline 404. The test item showed skin corrosive effects.
Eye irritation: The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. Severe eye damaging effects cat 1 were observed on one animal.

 

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no observation period of 14 days, no subdivision of the scores after 72 hourss
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
no data
Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12 animals
6 animals intact skin
6 animals abraded skin
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: By the method of Draize
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 3
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 4
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 5
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 6
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 4
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 5
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animal 6
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
After 24 hours, ischemia and slight to severe edema; after 72 hours, distinct or severe incrustation.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The skin irritation potential of the test substance was determined in a study equivalent to OECD guideline 404. The test item showed corrosive effects.
Executive summary:

The skin irritation potential of the test item was determined in a study equivalent to OECD guideline 404. The test substance was applied undiluted in an amount of 0.5 mL. Six rabbits are treated on the intact skin, the other six on the abraded skin. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. After an exposure period of 24 hours the patches were removed. The resulting skin reaction were read immediately after 24 hours and after 72 hours. The following scores are indicated as overall mean irritation scores after 72 hours. No subdivision was done for the scores after 72 hours:

Intact skin

Animal 1: 3

Animal 2: 3

Animal 3: 3

Animal 4: 3

Animal 5: 3

Animal 6: 4

Abraded skin

Animal 1: 3

Animal 2: 3

Animal 3: 4

Animal 4: 4

Animal 5: 4

Animal 6: 3

The test item showed skin corrosive effects. The effects were not reversibel after 72 h. After 24 hours, ischemia and slight to severe edema; after 72 hours, distinct or severe incrustation were observed.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal used
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye
Amount / concentration applied:
1/10 mL
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 rabbit
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No washing

SCORING SYSTEM: According to Draize

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritant / corrosive response data:
After 21 days the animals showed deformed eye-ball (ulcus cornea), moderate to severe corneal opacity, strongly vascularized fibroangioblastic tissue on cornea, iris and conjunctivae without visible damage.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. Severe eye damaging effects were observed on one animal.
Executive summary:

The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. An amount of 1/10 mL of the test substance was applied undiluted to the eye of one rabbit. The other eye served as control eye. The eyes are not washed following instillation. The eye are examined at 24, 48, 72 hours, 7 days, 14 days and 21 days after instillation. The following results were determined (mean value 24, 48 and 72 h):

Scores of the animal examined

Cornea: 2 -3

Iris: 1

Conjunctivae: 3

Chemosis: 3

The effects were not reversible after 21 days. The test item showed severe eye damaging effects cat .1.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation potential of the test item was determined in a study equivalent to OECD guideline 404. The test substance was applied undiluted in an amount of 0.5 mL. Six rabbits are treated on the intact skin, the other six on the abraded skin. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. After an exposure period of 24 hours the patches were removed. The resulting skin reaction were read immediately after 24 hours and after 72 hours. The following scores are indicated as overall mean irritation scores after 72 hours. No subdivision was done for the scores after 72 hours:

Intact skin

Animal 1: 3

Animal 2: 3

Animal 3: 3

Animal 4: 3

Animal 5: 3

Animal 6: 4

The test item showed skin corrosive effects. The effects were not reversibel after 72 h. After 24 hours, ischemia and slight to severe edema; after 72 hours, distinct or severe incrustation were observed.

Eye irritation

The eye irritation potential of the test item was determined in a study equivalent to OECD guideline 405. An amount of 1/10 mL of the test substance was applied undiluted to the eye of one rabbit. The other eye served as control eye. The eyes are not washed following instillation. The eye are examined at 24, 48, 72 hours, 7 days, 14 days and 21 days after instillation. The following results were determined (mean value 24, 48 and 72 h):

Scores of the animal examined

Cornea: 2 -3

Iris: 1

Conjunctivae: 3

Chemosis: 3

The effects were not reversible after 21 days. The test item showed severe eye damaging effects cat .1.

Justification for classification or non-classification

Eye irritation

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the test substance is considered to be classified as eye damaging cat. 1 H318 under Regulation (EC) No 1272/2008.

Skin Irritation

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the test substance is considered to be classified as skin corrosive cat. 1c H314 under Regulation (EC) No 1272/2008.