Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating in vivo ( similarly to US-FHSA guideline, K, rel. 2)

Eye irritation: not irritating in vivo (similar to OECD 405, KS, rel. 2)

Respiratory irritation: no data available

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 10 to 13, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Study performed similarly to US-FHSA guideline. Deviations from standard method : no details on test animals, test on intact and abraded skin, 24 h exposure instead of 4h, occlusive dressing instead of semi-occlusive, observation at 24 and 72 h only (no 48h scoring), no reversibility period although effects have been observed until the end of the study. However, considering the very worst case conditions used in this test (occlusive conditions, no removal of test item reported, abraded skin) and the low scores measured at 72h, a full recovery could be expected after a normal recovery period of 14 day. Therefore this study is considered sufficiently reliable to conclude for classification purposes.
Qualifier:
equivalent or similar to
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data
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 g
- Tested as supplied
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 h
Number of animals:
6
Details on study design:
TEST SITE (intact & abraded skin)
- Area of exposure: Side of the animal's back (one side abraded skin, the other side remains intact)
- Type of wrap if used: Treated areas were covered with gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize method.
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
24/72 h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
24/72 h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
other: animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
other: animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
other: no indication of irritation
Remarks:
24 and 72 h
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
other: animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
24 and 48h
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
other: animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
abraded
Basis:
other: animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
erythema score
Remarks:
abraded
Basis:
other: animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #3
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #5
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritation parameter:
edema score
Remarks:
abraded
Basis:
other: animal #6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no indication of irritation
Remarks:
Time point: 24/72 h (no 48 h scoring)
Irritant / corrosive response data:
- Slight to well defined erythema and slight to moderate oedema were observed under occlusive conditions.
- The average score in the abraded skin is similar to that for the intact skin, both under occlusive conditions.
- Reversibility is not observed at 72 h but the study terminated after 72 h, with no removal of residue (or at least not reported) after the treatment of test item to the skin and thus no observation period after removal of the substance (recovery period). The average scores observed are low and thus a full recovery could be expected after a normal recovery period of 14 day.
Other effects:
No data

Table 7.3.1/1: Mean irritant/corrosive response data for all animals at each observation time up to removal of animals from the test (intact skin)

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

24 h

0.83

0.00

72 h

1

0.83

Average 24h and 72h

0.91

0.41

Reversibility*)

n.

n.

Average time for reversion**

-

-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

 

Table 7.3.1/2: Irritant/corrosive response data for individual animals at each observation time up to removal of animals from the test (intact skin)

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

24 h

1 / 0 / 1 / 1 / 1 / 1

0 / 0 / 0 / 0 / 0 / 0

72 h

1 / 0 / 2 / 1 / 1 / 1

0 / 0 / 3 / 0 / 1 / 1

Average 24h and 72h

1 / 0 / 1.5 / 1 / 1 / 1

0 / 0 / 1.5 / 0 / 0.5 / 0.5

Reversibility*)

n.

n.

Average time for reversion**

-

-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test item is not classified as irritant according to Regulation (EC) No 1272/2008 (CLP) and to GHS.
Executive summary:

In a dermal irritation study, 0.5 g of undiluted test material was dermally applied on the intact and abraded skin of 6 albino rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.

The test material induced slight to well defined erythema and slight to moderate oedema to the intact skin but the individual average scores (24/72 h) are rather low (1/0/1.5/1/1/1 and 0/0/1.5/0/0.5/0.5, respectively) and far from average scores leading to classification for skin irritation (<2.3). Moreover, average scores in the abraded skin is similar to that for the intact skin, both under occlusive conditions.

Reversibility is not observed at 72 h but the study terminated after 72 h, with no removal of residue (or at least not reported) after the treatment of test item to the skin and thus no observation period after removal of the substance (recovery period). The average scores observed are low and thus a full recovery could be expected after a normal recovery period of 14 day.

Therefore, under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and to GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Reason / purpose:
data waiving: supporting information
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 July 09 to 16, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The study was performed according to 16 CFR 1500.42 (US) test guideline. The study was conducted prior to the OECD Test Guideline No. 405 but the protocol is similar to that guidance.
Qualifier:
according to
Guideline:
other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, p. 27019, 27 September 1973.
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No details on test animals and environmental conditions
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: Healthy young adult albino rabbits were used.

IN-LIFE DATES: From: July 09, 1979 To: July 16, 1979
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Eyes of the animals were not rinsed.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: According to “Illustrated guide for grading eye irritation by hazardous substances”.

TOOL USED TO ASSESS SCORE: No data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- Animals showed conjunctival reactions (redness, chemosis and discharge) which were reversible within 5 days.
Other effects:
None

Table 7.3.2/1: Mean eye irritation response data of 6 animals at each observation time

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

24 h

0

0

0

0.83

0.67

1

48 h

0

0

0

0.33

0.17

0.33

72 h

0

0

0

0

0.17

0.33

Mean

0

0

0

0.39

0.33

0.55

Reversibility

-

-

-

Completely

reversible

Completely reversible

Completely reversible

Average time for reversion

-

-

-

3 days

5 days

5 days

Table 7.3.2/2: Eye irritation response data for each animal at each observation time

Score at time

point

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

24 h (Day 1)

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

1 / 2 / 1 / 0 / 0 / 1

1 / 1 / 1 / 0 / 0 / 1

1 / 3 / 2 / 0 / 0 / 0

48 h (Day 2)

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 2 / 0 / 0 / 0 / 0

0 / 1 / 0 / 0 / 0 / 0

0 / 2 / 0 / 0 / 0 / 0

72 h (Day 3)

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 1 / 0 / 0 / 0 / 0

0 / 2 / 0 / 0 / 0 / 0

Day 5

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

Day 7

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

Average 24, 48 and 72 h

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0 / 0 / 0 / 0 / 0 / 0

0.33 / 1.33 / 0.33 / 0 / 0 / 0.33

0.33 / 1 / 0.33 / 0 / 0 / 0.33 

0.33 / 2.33 / 0.67 / 0 / 0 / 0

Reversibility

 -

 -

-

Completely

reversible

Completely reversible

Completely reversible

Average time (unit) for reversion

-

-

-

3 days

5 days

5 days

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material induced mild irritation being reversible within 5 days. Therefore, the test material is not classified as irritant to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study, 0.1 g of undiluted test material was instilled into the right eye of 6 albino rabbits while the left eye remained untreated and served as control. The eyes were not rinsed after the instillation of test material. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the “Illustrated guide for grading eye irritation by hazardous substances”.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were as follows: 0.33 / 1.33 / 0.33 / 0 / 0 / 0.33 for redness, 0.33 / 1 / 0.33 / 0 / 0 / 0.33 for chemosis, 0 / 0 / 0 / 0 / 0 / 0 for iris lesions and 0 / 0 / 0 / 0 / 0 / 0 for corneal opacity. The observed conjunctival reactions were fully reversible within 5 days.

Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

A key study was available on the substance (Borriston, 1979, Rel.2). In this dermal irritation study, undiluted test material was dermally applied on the intact and abraded skin of 6 albino rabbits under occlusive conditions for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch. The individual average scores (24/72 h) were 1/0/1.5/1/1/1 for erythema and 0/0/1.5/0/0.5/0.5 for Oedema, too low for classification. Moreover,average scores in the abraded skin is similar to that for the intact skin, both under occlusive conditions. Reversibility is not observed but the study terminated after 72 h, with no removal of residue (or at least not reported) after the treatment of test item to the skin and thus no observation period after removal of the substance (recovery period). The average scores observed are low and thus a full recovery could be expected after a normal recovery period of 14 day.

Thus the registered substance does not require classification for skin irritation.

Eye irritation:

A study was available on the substance itself regarding eye irritation (Biosearch, 1979, Rel.2). This eye irritation study was performed prior to the OECD test guideline No. 405 but the protocol is similar to that guidance. Undiluted test material was instilled into the eye of 6 rabbits. The eyes were not rinsed after instillation of the test item. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on Days 5 and 7.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were as follows: 0.33 / 1.33 / 0.33 / 0 / 0 / 0.33 for redness, 0.33 / 1 / 0.33 / 0 / 0 / 0.33 for chemosis, 0 / 0 / 0 / 0 / 0 / 0 for iris lesions and 0 / 0 / 0 / 0 / 0 / 0 for corneal opacity. The observed conjunctival reactions were fully reversible within 5 days.

Thus the registered substance does not require classification for eye irritation.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available data:

- No additional self-classification is proposed regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

- No additional self-classification is proposed regarding eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

- No information was available regarding respiratory irritation. However, the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.