Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion
Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant to the rabbit's skin.
Six rabbits were exposed to the test material for 4 hours. No full destruction of the skin was observed. Therefore it can be concluded that the test material is not corrosive.
Eye irritation
The test substance was installed in the eye of 6 rabbits. During the 14 day observation period severe eye irritation is observed. The test substance is considered to be an eye irritant category 1.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
existing in-vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
limited report, non-GLP, test with formulation. limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.
Qualifier:
according to guideline
Guideline:
other: FHSLA, CFR Title 21, para. 191.11
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Bodyweight: 2.3 to 3.0 kg
No further details
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% in diluent oil

Duration of treatment / exposure:
24 hours
Observation period:
scored 24 and 72 hours after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- Abrasions made over 2-3 cm2
- Type of wrap if used: plastic trunk band to prevent evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done):none

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
ca. 3.66
Reversibility:
not reversible
Remarks on result:
other: score for non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
ca. 0.16
Reversibility:
not reversible
Remarks on result:
other: score for non-abraded skin
Irritant / corrosive response data:
The results are presented for the abraded and non-abraded skin.
Other effects:
none reported
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material is irritating to the rabbit's skin.
Executive summary:

Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
existing in-vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited report, non GLP. The information in the report is limited to the information in the summary.
Qualifier:
according to guideline
Guideline:
other: FHSLA, CFR, TitIe 21. para . 191. 12.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no details reported
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 40%

Duration of treatment / exposure:
NA
Observation period (in vivo):
14 days, scored at 24, 48 and 72 hours and 4, 7 and 14 days after installation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not reported
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.9
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 3.1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
irritant
Other effects:
Not reported

Animal no

1

2

3

time

24

48

72

4

7

14

24

48

72

4

7

14

24

48

72

4

7

14

cornea

1

1

1

1

1

1

1

1

1

1

1

1

2

2

2

1

1

1

iris

1

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

3

3

3

3

3

3

3

3

3

2

2

2

3

3

3

3

3

3

chemosis

3

3

2

2

3

2

4

3

2

2

2

2

4

3

2

2

2

1

discharge

3

3

3

2

2

2

3

3

2

2

2

2

3

3

3

2

2

2

Animal no

4

 

 

 

 

 

5

 

 

 

 

 

6

 

 

 

 

 

time

24

48

72

4

7

14

24

48

72

4

7

14

24

48

72

4

7

14

cornea

2

2

2

1

1

1

2

2

2

2

2

2

1

1

1

1

1

1

iris

2

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

3

3

3

3

3

2

3

3

3

3

3

3

3

3

3

3

3

3

chemosis

4

3

3

2

2

2

4

3

3

2

2

2

3

3

3

3

2

2

discharge

3

3

3

2

2

2

3

3

3

3

2

2

3

3

3

2

2

2

 

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is a severe eye irritant
Executive summary:

The test substance was installed in the eye of 6 rabbits. During the 14 day observation period severe eye irritation is observed. The test substance is considered to be an eye irritant category 1.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 40% formulation. It is not expected that the diluent used has contributed to the effects if any.


Justification for selection of skin irritation / corrosion endpoint:
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Exposure duration in both the irritation as well as the corrosion test represent a worst case situation.

Justification for selection of eye irritation endpoint:
Study was conducted prior to GLP regulations but used a method similar to OECD 405

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the outcome of the available tests, the test substance needs to classified as skin irritant (CLP category 2, H315: Causes skin

irritation) and severe eye irritant (CLP category 1, H318: Causes serious eye damage).