Registration Dossier

Administrative data

Description of key information

The substance is not irritating to the skin and 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAVO; MED. versuchstierzuchten GMBH, 7964 Kisslegg/Allgau, FRG
- Weight at study initiation: males 2.02 and 2.05 kg and female 2.02 kg
- Housing: One animal per cage, stainless steel with wire mesh walk floors (floor area: 40 x 51 cm). No bedding in the cages.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: About 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL undiluted test substance
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 (2 males 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks, clipped at least 15 hours before the beginning of the study.
- Type of wrap if used: The test patches were secured in position with a porous dressing. Four layers of absorbent gauze + porous bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: at the end of the application period (4 hours)


Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48, and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48, and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated 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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO; MED. versuchstierzuchten GMBH, 7964 Kisslegg/Allgau, FRG
- Weight at study initiation: males 2.44 and 2.56 kg and female 2.62 kg
- Housing: One animal per cage, stainless steel with wire mesh walk floors (floor area: 40 x 51 cm). No bedding in the cages.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: About 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL undiluted
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Application: Single instillation into the conjunctival sac of the right eyelid
- The test substance was not washed out.
- Readings: 1 h, 24 h, 48 h and 72 h after instillation.
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Clearly increased discharge was observed in all animals 1 hour after instillation of the test substance. Slight conjunctivae redness was observed in two animals and was fully reversible within 48 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An in vivo skin irritation study was conducted according to the OECD 404 guideline. Three Vienna White rabbits were exposed to 0.5 mL undiluted test substance under semiocclusive conditions. The substance was applied on a 2.5 x 2.5 cm clipped area. Animals were exposed for 4 hours and after exposure the substance was washed off with Lutrol and water. The rabbits were observed for 8 days. Very slight erythema was observed in all animals 24, 48, and 72 hours after exposure. No edema was observed. Symptoms were reversible within 8 days. Under the conditions of the test, the substance is not skin irritating.

An in vivo eye irritation study was conducted according to the OECD 405 guideline. Three Vienna White rabbits were exposed to 0.1 mL undiluted test substance. The substance was applied in the conjunctival sac of one eyelid. The test substance was not washed out. Effects were observed for 72 hours. Clearly increased discharge was observed in all animals 1 hour after instillation of the test substance. Slight conjunctivae redness was observed in two animals which was fully reversible within 48 hours. Under conditions of the test, the substance is not eye irritating.


Justification for selection of skin irritation / corrosion endpoint:
only study available

Justification for selection of eye irritation endpoint:
only study available

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for skin and eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.