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Description of key information

Studies were done according to corresponding guidelines and under GLP conditions.

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:
From 2 August 1991 to 26 November 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 19 weeks
- Weight at study initiation: 3260-3362 grams
- Diet (e.g. ad libitum): 100 grams per day
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21ºC
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7, 14 and 21 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: one flack, surgical gauze patch 2x3 cm

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7d: 2, 14d:0, 21d:1
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 7d: 2, 14d:0, 21d:0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7d: 2, 14d:1, 21d:1
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7d: 0, 14d:1, 21d:2
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7d: 2, 14d:1, 21d:1
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 7d: 1, 14d:1, 21d:1
Remarks on result:
positive indication of irritation

Observation time Rabbit no. Erythema 679 Oedema Rabbit no. Erythema 680 Oedema Rabbit no. Erythema 681 Oedema
24 hours 2 3 4 2 2 3
48 hours 2 3 4 2 3 2
72 hours 2 2 4 2 4 2
Mean value 2 2,7 4 2 3 2,3
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The substance resulted in a primary irritation index 5.3 (severaly irritating) when applied to the intact rabbit skin.
Executive summary:

This study was entitled "Primary skin irritation/corrosion study with the substance in the rabbit (4-hour semi-occlusive application)".

The purpose of this study was to assess the possible irritation or corrosion potencial of the substance when a single dose was placed on the skin of rabbits. Under the conditions of this study, the substance resulted in well defined or severe erythema and slight or moderate oedema in the three animals. The skin irritation had not resolved within the study period and no corrosive effect occurred on the skin in all three animals.

The substance resulted in a primary irritation index of 5.3 (severely irritating) when applied to intact rabbit 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
Study period:
From 19 August 1991 to 26 August 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 17 weeks
- Weight at study initiation: 2825-2910 grams
- Diet (e.g. ad libitum): 100 g per day
- Water (e.g. ad libitum): free access
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remained untreated and served as the reference control
Amount / concentration applied:
0.1 mL per animal
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48 and 72 hours and 7 days after test substance administration
Number of animals or in vitro replicates:
three female albino rabbits
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no irritation at 72 h after treatment
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: no irritation at 72 h after treatment
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: no irritation at 72 h after treatment
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:
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:
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:
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation at 72 h after treatment
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation

DRAIZE SCORE CALCULATION

Hours/days after application
Animal No. Tissue 1 hour 24 hours 48 hours 72 hours 7 days
732 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 4 4 2 0
Subtotal 6 4 4 2 0
733 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 8 6 2 0
Subtotal 6 8 6 2 0
734 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae 6 8 2 2 0
Subtotal 6 8 2 2 0
TOTAL 18 20 12 6 0
MEAN TOTAL 6 6,7 4 2 0

Calculations for EEC classification

Animal No. Observation time after application Corneal opacity Iris lesion Conjunctivae redness Conjumctivae chemosis
732 24 hours 0 0 2 0
48 hours 0 0 1 0
72 hours 0 0 1 0
Mean value 0 0 1,3 0
733 24 hours 0 0 2 1
48 hours 0 0 2 1
72 hours 0 0 1 0
Mean value 0 0 1,7 0,7
734 24 hours 0 0 2 1
48 hours 0 0 1 0
72 hours 0 0 1 0
Mean value 0 0 1,3 0,3
Interpretation of results:
GHS criteria not met
Conclusions:
The substance was considered not irritant to the rabbit eye and it need not be labeled as an eye irritant according to GHS and CLP
Executive summary:

This study was entitled "Acute eye irritation/corrosion study with the substance in the rabbit". This study was carried out in accordance with OECD Guideline No.405, "Acute eye irritation/corrosion.

Under the conditions of this study, the substance resulted in adverse effects on the conjuctivae in all three animals, which had resolved within 7 days. Ocular corrosion was not observed in any of the animals. The substance was considered not irritant to the rabbit eye according to GHS and to CLP

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance is irritating for skin. The substance is mildly irritating to eyes, but not sufficient for classification.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

- skin irritation / corrosion:

Based on the above stated assessment of the skin irritation / corrosion test, the results show that the test item is irritating to skin and needs to be classified as "R38 Irritating to skin" according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or as Category 2, "Warning - H315: Causes skin irritation" according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- eye irritation / corrosion:

Based on the above stated assessment of the eye irritation test, the results show that the test item is not eye irritating and does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.