Registration Dossier

Administrative data

Description of key information

Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating.
Based on the results of a study according to OECD Test Guideline 431 under GLP, the test substance is considered as not skin corrosive.
Based on the results of a study according to OECD Test Guideline 405, the test substance is considered as corrosive to the eye.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes
Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit diet "Altromin 2123" from Altromin; ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times / hour
- Photoperiod: 12 hrs dark / 12 hrs light

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4h
Observation period:
21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: two 16-layer gauze patches (2.5 x 2.5 cm)
- Type of wrap if used: Micropore tape, 5 cm width

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after termination of exposure as well as 7, 14 and 21 days

SCORING SYSTEM:
- Method of calculation: The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Interpretation of results:
Category 2 (irritant)
Conclusions:
Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.

The amount of 0.5 ml of the substance was applied unchanged under semi-occlusive conditions for 4 hours to the clipped skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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 7 days of observation
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LSR Industries, Union Grove, WI
no further information

ENVIRONMENTAL CONDITIONS : no data

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: second eye served as negative control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24h
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): Yes, with 0.9% Saline
- Time after start of exposure: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4 d
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 4 d
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
7 d
Score:
2
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
7 d
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
7 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicles seen
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 4 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 1 h
Score:
3
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 4 d
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
7 d
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 1 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 4 d
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
7 d
Score:
1
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 4 d
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
7 d
Score:
2
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 1 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 4 d
Score:
4
Max. score:
4
Remarks on result:
other: vesicle formation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
7 d
Score:
2
Max. score:
4
Remarks on result:
other: vesicle formation
Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
Based on the results of a study according to OECD Test Guideline 405, the test substance is considered as severly irritating to the eye (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405.

The amount of 0.1 ml of the substance was applied unchanged for 24 hours to the eyes of six New Zealand White rabbits, which were observed for 7 days post application. Over the first three days, clear effects (cornea, iris, conjunctivae and chemosis) were observed, which did not fully reverse within 7 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as severely eye irritating as at the end of the observation period effects still persisted.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An in vitro study according to OECD test guideline 431 showed that the test substance is not skin corrosive. This complements the results of an in vivo study according to OECD Test Guideline 404, in which clear, but reversible (after 21 days) erythema and oedema were observed, but no corrosive effects.

Eye irritation was assessed in vivo according to OECD Test Guideline 405. Adverse effects on iris, cornea and conjunctivae were observed, which had not fully reversed at the end of the observation period, i.e. day 7. It remains unknown, if these effects would have reversed within 21 days.

Justification for classification or non-classification

Skin irritation/corrosion:

Interpreting the results of both the in vitro and in vivo test by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.

Eye irritation:

Interpreting these results the results of the in vivo test by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as corrosive to the eye, because the study was terminated at observation day 7, although effects still persisted.