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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The test item has no skin or eye irritating effects in rabbits

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11
Version / remarks:
February 1965
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation (means): males: 2.58 Kg; females: 2.73 Kg
- Housing: single
- Diet ad libitum: Styles-Oxoid
- Water ad libitum: sterile filtered water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 to 70
- Photoperiod (hrs dark / hrs light): 14/10

IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Remarks:
left side shaved; right side shaved and abraded
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL per test site
- Concentration (if solution): 1000 mg/mL

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males + 3 females
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: at least 10%
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Coban" self adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Remarks:
of 6 animals
Time point:
24 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
2.83
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Remarks:
intact and abraded skin
Basis:
mean
Time point:
other: 24 + 72 h
Score:
2.08
Max. score:
8
Remarks on result:
probability of mild irritation
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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12
Version / remarks:
February 1965
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation (means): males: 2.58 Kg; females: 2.73 Kg
- Housing: single
- Diet ad libitum: Styles-Oxoid
- Water ad libitum: sterile filtered water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 to 70
- Photoperiod (hrs dark / hrs light): 14/10
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
3 rabbits: 30 sec
3 rabbits: 1 hour
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males + 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 rabbits with warm water
- Time after start of exposure: in 3 rabbits after 30 seconds

SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight reddening, swelling and discharge was observed in all animals 1 hour after treatment. Two rabbits still showed minimal reddening 24 hours after treatment, which was no longer visible at 48 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item ha no irritating effects in rabbit eyes
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification