Registration Dossier

Administrative data

Description of key information

The substance is not irritating for the skin as well as eyes.

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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See chapter 13 for detailed read across justification.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2370 t o 2580 g
- Housing: individually in metal cages, identified with individually numbered ear tags ,
- Diet: ad libitum standard rabbit pellet - Nafag
No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

IN-LIFE DATES: From: February 3, 1987 To: February 10, 1987
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: one flank of each animal served as a control flank
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square cm

OBSERVATION TIME POINTS
- 1, 24, 48, and 72 hours after removing the gauze patches

SCORING SYSTEM:
- Method of calculation: OECD scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Other effects:
A moderate loss of weight was observed in animal No. 31 on day 3 and 7.

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40284/A is considered to be not a skin irritant.
Executive summary:

An acute skin irritation/corrosion study in albino rabbits was performed to determine, the irritant or corrosive potency of FAT 40284/A on the albino rabbit skin. This test was based on the OECD guideline No. 404. The test was performed on 3 male rabbits. A gauze patch (20 cm) bearing 0.5 g of the test substance was applied to the shaved flank. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Under the experimental conditions employed FAT 40284/A induced erythema and edema reactions when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance FAT 40284/A can be classified as non-irritant.

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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer chapter 13 for detailed read across justification.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Test substance: FAT 40284/A
Batch No.: EN 47342.52
Contents of active ingredients : 29.3 %
Physical properties: powder; dispersible in water; pH: 9.0 (lg/1 water)
Storage conditions: room temperature
Validity: November 1991
Safety precautions: gloves and face masks
Test material received: December 12, 1986
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2310 t o 2600 g
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C,
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

IN-LIFE DATES: From: February 10, 1987 To: February 17, 1987
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control.
Amount / concentration applied:
0.1 ml (54 mg)
Observation period (in vivo):
7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40284/A can be classified as non - irritant to the eyes.
Executive summary:

An acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 40284/A on the albino rabbit eye and the associated mucous membranes. This test was based on the OECD guideline No. 405. The test was performed on 3 male rabbits. 0.1 ml (54 mg) of FAT 40284/A was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40284/A according to the OECD scoring system. FAT 40284/A induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits. Because the mean values of the readings 24 to 72 hours after application are below the threshold of significance, FAT 40284/A can be classified as non - irritant.

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

Additional information

Skin irritation:

An acute skin irritation/corrosion study in albino rabbits was performed to determine, the irritant or corrosive potency of FAT 40284/A on the albino rabbit skin. This test was based on the OECD guideline No. 404. The test was performed on 3 male rabbits. A gauze patch (20 cm) bearing 0.5 g of the test substance was applied to the shaved flank. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Under the experimental conditions employed FAT 40284/A induced erythema and edema reactions when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance FAT 40284/A can be classified as non-irritant.

Eye irritation:

An acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FAT 40284/A on the albino rabbit eye and the associated mucous membranes. This test was based on the OECD guideline No. 405. The test was performed on 3 male rabbits. 0.1 ml (54 mg) of FAT 40284/A was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40284/A according to the OECD scoring system. FAT 40284/A induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits. Because the mean values of the readings 24 to 72 hours after application are below the threshold of significance, FAT 40284/A can be classified as non - irritant.

Justification for classification or non-classification

Based on the available data, FAT 36002 does not warrant the classification according to the CLP Regulation (EC 1272/2008).