Registration Dossier

Administrative data

Description of key information

assessment used to read across:
Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
In deviation of modern guidelines occlusive patches were used in this study, representing exaggerated exposure conditions.
Principles of method if other than guideline:
The procedure used is based, but not in every part identical with the proposed guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study". Federal Register, Vol 43 No. 163, August 22, 1978.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
adraded skin
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days

Erythema score after 24, 48 and 72 h (animal1/2/3/4/5/6)

 Exposure time  24 h  48 h  72 h  
 intact skin  2/2/2/2/1/1   2/2/2/2/1/1  1/2/1/1/0/0
 abraded skin  2/1/0/2/1/1   1/1/0/2/1/1  1/0/0/0/0/0

Edema score after 24, 48 and 72 h (animal1/2/3/4/5/6)

 Exposure time  24 h  48 h  72 h
intact skin  1/2/1/0/0/0  1/1/1/0/0/0 0/1/0/0/0/0
abraded skin  1/1/0/1/0/0  1/0/0/0/0/0 1/0/0/0/0/0

All effects were fully reversible within 7 days (all scores: 0.0). There was no staining of the treated skin.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to skin.
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Principles of method if other than guideline:
The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study".
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single exposure; in 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of sterile physiological saline.
- Time after start of exposure: In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.


TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no reactions
Irritation parameter:
iris score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no reactions
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h

Findings animal 1/2/3 (undiluted test substance, eyes not washed out):

 Time   Opacity Iritis  Erythema  Chemosis                  
24 h 0/0/0 0/0/0 0/1/1 1/0/0                  
48 h

0/0/0

 0/0/0 0/1/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0  0/0/0 0/0.7/0.3 0.3/0/0                  

Findings animal 4/5/6 (undiluted test substance, eyes washed out):

 Time   Opacity Iritis    Erythema Chemosis                  
24 h 0/0/0  0/0/0 1/0/0 0/0/1                  
48 h

0/0/0

 0/0/0 0/0/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0 0/0/0 0.3/0/0 0/0/0.3                  

FAT 65'023/L was found to cause mild irritation when applied to the rabbit eye mucosa.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin:

In a primary dermal irritation study with a close structural analogue (CAS 16090 -02 -1), 6 New Zealand White rabbits were dermally exposed to 0.5 mL of test substance for 24 hours under occlusive conditions. Animals then were observed for 7 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 1.4 and for edema was 0.4. The skin reactions observed were fully reversible until the end of the observation period on day 7. In this study, the tested substance CAS 16090-02-1) is not a dermal irritant.

Due to the consistent observation that the substance does not induce skin irritation it is concluded that the substance CAS 133 -66 -4 is also not irritating to skin and has not to be classified as skin irritation.

Eye:

An eye irritation test was performed with three New Zealand White rabbits on a close structural analogue (CAS 16090 -02 -1). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for iritis and cornea opacity were 0 at any reading time point. For conjunctivae redness the mean score was 0.3 and for conjunctivae chemosis 0.1. The eye reactions observed were fully reversible within 72 and 48 hours, respectively. In this study the family member (CAS 16090-02-1) is not an eye irritant.

Due to the consistent observation that the substance does not induce eye irritation it is concluded that the substance CAS 133 -66 -4 is not irritating to eye and has not to be classified as eye irritant.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Regulation (EC) No. 1272/2008.