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Administrative data

Description of key information

In two in vivo skin irritation studies, zirconium basic sulfate was found not to be irritating to rabbit skin. Both studies were performed according to OECD guideline 404 (Clouzeau, 1994; Cuthbert and Jackson, 1992b).
In an ocular irritation test, performed according to OECD Guideline 405, zirconium basic sulfate was found not to be irritating to rabbit eyes (de Jouffrey, 1995).

Key value for chemical safety assessment

Skin irritation / corrosion

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 22-12-1994 to 25-12-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 405 without deviations.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Animals are housed individually in polystyrene cages with a food and water supply system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
The substance is not rinsed from the eye until the end of the 72 h treatment.
Observation period (in vivo):
at 1, 24, 48 and 72 hours after product administration
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE: not performed

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: fluorescein / UV lamp
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Only slight ocular reactions were observed during 48 hours after treatment. No effect was noted 72 hours after treatment. The mean score over 24, 48 and 72 hours for each animal was 0.0, 0.0 and 0.3 for chemosis, 1.0, 0.7 and 1.0 for redness of the conjunctiva and 0.0 for iris and cornea.
Other effects:
Tearing was observed in 2 animals at 1 hour after application, which was reversible within 24 hours.
A purulent whitish matter was present in the eye of the third animal 1 day after administration, and was gone the day after.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this test, zirconium basic sulfate was considered non-irritant when administered by ocular route in rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

Two skin irritation studies were performed in New Zealand White rabbits. Both studies were included in a weight of evidence approach. In the study of Clouzeau (1994, Klimisch 1), the dermal irritancy potential of zirconium basic sulfate was investigated by a semi-occlusive application of the test substance to the left (3 minutes) and right (1 and 4 hours) side of a New Zealand White rabbit (animal 1). Based on the results of animal 1 (product not very irritating), 2 other animals were tested. After 4 hours of exposure, the test substance was removed with a dry gauze. Erythema and edema were scored based on the Draize scoring system at 1, 24, 48 and 72 hours after removal of the test substance. Erythema score for animal 1 was 0.3 and fully reversible within 48 hours; for animals 2 and 3 the score was 0. The mean edema score for the 3 animals was 0. The skin irritation study of Cuthbert and Jackson (1992b, Klimisch 2) yielded similar observations. No skin reactions were noted following semi-occlusive applications of the test material to the skin of 3 rabbits for periods of 3 minutes, 1 and 4 hours. Under the conditions of these tests, zirconium basic sulfate was observed to be not irritating to rabbit skin.

Eye irritation:

In the Klimisch 1 key study, de Jouffrey (1995) investigated the eye irritation potential of zirconium basic sulfate in 3 New Zealand White rabbits. 100 mg of the test substance was instilled in rabbit eye. 1, 24, 48 and 72 hours after substance administration rabbit eyes were scored for chemosis, conjunctival redness, iris and cornea according to the Draize score. The mean result for chemosis for animals 1 to 3 was 0, 0 and 0.3 respectively. The latter score was reversible within 48 hours. The mean score for conjunctiva for animals 1 to 3 was respectively 1, 0.7 and 1 and scores were fully reversible within 72 hours. The mean iris and cornea score for the 3 animals was 0. Under the experimental conditions of this test, zirconium basic sulfate was considered non-irritant when administered by ocular route in rabbits.


Justification for selection of skin irritation / corrosion endpoint:
A weight of evidence approach including two in vivo OECD 404 studies performed with zirconium basic sulfate is used for endpoint coverage (Clouzeau, 1994; Cuthbert and Jackson, 1992b).

Justification for selection of eye irritation endpoint:
One Klimisch 1 study is available for zirconium basic sulfate (de Jouffrey, 1995). This study is considered as key study.

Justification for classification or non-classification

Based on the test results and the criteria of the CLP Regulation, zirconium basic sulfate should not be classified for skin or eye irritation.