Registration Dossier

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Description of key information

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:
23.4-30.4.2002
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
yes
Remarks:
The patches were removed after 4 hours and 20 minutes of exposure to the substance (due to a scheduling conflict). Based on the minimal irritation observed in the study, this deviation had no material effect on the results of this study.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: New Zealand albino
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
the test substance was moistened with distilled water to aschieve a dry paste by preparing a 70% w/w mixture.
Controls:
no
Duration of treatment / exposure:
The patches were removed after 4 hours and 20 minutes of exposure to the test substance.
Observation period:
1, 24, 48 and 72 hours and at 7 days after patch removal.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period.
Number of animals:
3 (2 males and 1 female)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: PDI for 1, 24, 48 and 72 h
Score:
1.1
Interpretation of results:
not irritating
Remarks:
Migrated information according to CLP Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for primary skin irriation according to OPPTS 870.2500 (Acute Dermal Irritation), and does not meet the criteria for classification as Irritant according to Regulation (EC) No 1272/2008 (CLP).
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:
29.4-2.5.2002
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Received from Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: Yound adult
- Housing: the animals were singly housed in suspended stainless steel caging. Litter paper was placed beneath the cage and was changed at least three times/week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by automatic water dispensing system.
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05-0.06g
Duration of treatment / exposure:
1 instillation at Day 1.
Observation period (in vivo):
Ocular irritation was evaluatet at 1, 24, 48 and 72 hours post-instillation.
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM:
The time interval with the highest measn score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra (J.Sos.Cos.Chem 1962; 13:281-289)


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Ocular irritation was evaluated using a high-intensity which light (Mag Lite) in accordance with Draize et al. (J.Pharmacol.Exp.Ther. 1944;82:377-390)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritant / corrosive response data:
All animals appeared active and healthy. Apart from conjunctivae redness in one animal after 24 h, there were no other signs of gross toxicity, adverse pharmacologic effect or abnormal behavior. No corneal opacity or irititis was observed in any treated eye during the study.
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The substance was tested for primary eye irriation according to OPPTS 870.2400, and does not meet the criteria for classification as Irritant according to Regulation (EC) No 1272/2008 (CLP).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Two GLP studies on the substance are part of the dossier; primary skin irritation in rabbits and primary eye irritation in rabbits.

With a Primary Dermal Irritation Index (PDII) of 1.1, the substance was considered as “slightly irritating for skin” according to the OPPTS classification system (1998). The mean scores for erythema or for oedema were however well below the criteria for classification according to CLP.

In the primary eye irritation study, the test substance was considered “minimally irritating to the eye”. The scores for Cornal opacity, Irititis, Conjunctival redness and Conjunctival oedema were well below the criteria for classification according to CLP.

Justification for classification or non-classification

The substance does not fulfill the classification criteria for skin and eye irritation according to CLP.

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