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Administrative data

Description of key information

GLP OECD 404: not irritating

GLP OECD 405: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 07, 1992 - June 12, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Batch: E919140



Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%

IN-LIFE DATES: From: day 1 To: day 8
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g per animal
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 (2 male & 1 females)
Details on study design:
TEST SITE
- Area of exposure: left side of the animal back (Test item), right side of the animal back (Carrier)
- Type of wrap if used: polyethylene foil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
Evaluation of skin reactions according to OECD 404
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:
Day 1: 0.0 (1 hour)
Day 2: 1.3 (24 hours)
Day 3: 1.3 (48 hours)
Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Study design

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of liquid paraffin to ensure good contact to the skin. Afterwards, the test material was spread onto 4 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under occlusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for further 7 days.

Results

In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:

Day 1: 0.0 (1 hour)

Day 2: 1.3 (24 hours)

Day 3: 1.3 (48 hours)

Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Conclusions

According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3. Thus, the test item is considered to be a skin irritant.
Executive summary:

This study was performed according to GLP and methods applied are fully compliant with OECD TG 404. According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For this endpoint information from a structural similar compound, 1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 404. See chapter 13 report for a more detailed justification.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the structural analogue material, the test item is not considered to irritant to rabbits' skin as all animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 07, 1992 - June 12, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD 1981, updated Guideline adopted Februaty 24, 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Batch: E919140



Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%

IN-LIFE DATES: From: day 1 To: day 8
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g per animal
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 8 of the experimental part
Number of animals or in vitro replicates:
3 (1 male & 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according OECD-Guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
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
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversibke wihtin 48 hours.
Other effects:
none

Study design

To test for primary eye irritation, the test material was instilled into the conjunctival say of rabbits. The first examination of the treated eye followed 1 hour after instillation. The examinations were performed daily for further 7 days.

Results

In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversible within 48 hours. The animal's individual mean scores (considering readings at 24 h, 28 h, and 72 h after installation of the test material) were below 1.0.


Conclusion

According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.

Interpretation of results:
GHS criteria not met
Conclusions:
According to these results, the test item is not considered to be classified as eye irritant as all animal's individual mean scores (considering readings at 24 h, 48 h and 72 h after installation of the test material) were below 1.0.
Executive summary:

The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes there is no need for classification for eye irritation.


Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For this endpoint information from a structural similar compound, 1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene, is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 405. See chapter 13 report for a more detailed justification.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
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
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the structural anlogue substance, the test item is not considered to be classified as eye irritant as all animal's individual mean scores (considering readings at 24 h, 48 h and 72 h after installation of the test material) were below 1.0.
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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

The informtion for these endpoints was obtained from an experimental studies. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 404 and 405. Based on the provided information, the test item is not considered to be classified as skin or eye irritant according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.