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Description of key information

Skin corrosion: not irritating


Eye irritation: not irritating

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:
4 October 1983 to 7 October 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP statement dates to Dec 18, 1987 Study report dates to Oct 14, 1983
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: The animals were caged individually in stainless steel cages
- Diet: ad libitum, pelleted standard Kliba 341, rabbit maintenance diet
- Water: ad libitum, tap water
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of the moistened (tap water) test substance

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: on the dorsum of each rabbit
- Test patch approximately 3.0 cm x 3.0 cm
- Type of wrap: impermeable material and fastened to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h (at the end of the exposure period)

OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1 hour, 24, 48, 72 hours following removal of bandages and gauze patch.

SCORING SYSTEM:
A numerical scoring system according to Draize J.H. 1959 was used to grade the skin lesions.
Irritation parameter:
edema score
Basis:
animal: #32
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #32
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #33
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #33
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #34
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #34
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance showed a primary irritation index of 0 when applied to intact rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
Interpretation of results:
GHS criteria not met
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:
4 October 1983 to 07 October 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP statement dates to Dec 18, 1987 Study report dates to Oct. 26, 1983
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.2-2.3 kg
- Housing: The animals were caged individually in stainless steel cages
- Diet: ad libitum, pelleted standard Kliba 341, rabbit maintenance diet (Klingentalmuehle AG, CH 4303 Kaiseraugst/Switzerland)
- Water: ad libitum, tap water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
other: The right eye was untreated and served as control.
Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g/rabbit (left eye)
Duration of treatment / exposure:
The study was terminated 72 hours after administration of the test substance.
Observation period (in vivo):
72 h
Details on study design:

SCORING SYSTEM: numerical scoring system was used to grade the ocular lesions (according to Draize J.H. 1959).

Irritation parameter:
cornea opacity score
Basis:
animal: #29
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #29
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #29
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #29
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #30
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #30
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #30
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #30
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #31
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #31
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #31
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #31
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
After 1 h of administration all animals showed conjunctivae redness score 1, which was fully reversible after 24 hrs.
No corrosion of the cornea was observed at any of the measuring intervals.
No discoloration of the cornea and conjunctivae related to effects of the test article observed.
No acute toxicity or mortality were found.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential of the test substance to cause skin irritation was tested in an OECD guideline 404 study according to GLP. Three rabbits were treated with 0.5 g moistened test material on a 3 x 3 cm patch to the clipped skin for four hours under occlusive wrap. At the end of the treatment period, the test material was removed and skin reactions were monitored. No mortality, toxicity or clinical signs were observed. No skin reactions were noted at any time point, therefore the study was terminated 72 hours following test substance administration. Based on these findings, the test substance was not irritating to the skin.


 


 


The potential of the test substance to cause eye irritation was tested in an OECD guideline 405 study according to GLP. Three rabbits were treated with 0.1 g unchanged test substance in the conjunctival sac of the left eye, the right eye remained untreated as control. Animals were checked at 1h, 24, 48h and 72h after test substance application for effects on the eyes. Slight conjunctival redness (score 1) was observed at 1h, no effects were recorded at 24, 48 or 72 hours after test substance application. Due to the lack of findings, the study was terminated after 72 hours. Based on these results, the test material was found to be not irritating to the eye.

Justification for classification or non-classification

Based on the data available, the test item does not meet criteria for classification laid down in Regulation (EC) 1272/2008 (CLP).

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