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Description of key information

The results of the skin irritation study according to OECD 404 indicate that the target substance and Category Member 2, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item. That result is supported by a skin irritation study on the Category Member 3, 2-decyltetradecanoic acid. 
The results of the eye irritation study according to OECD 405 indicate that the target substance and Category Member 2, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item. That result is supported by an eye irritation study on the Category Member 3, 2-decyltetradecanoic acid.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como), Italy (supplier), P. O. A. D. A., Mandello Lario (Como),Italy (breeder)
- Age: 9 – 11 weeks
- Weight at study initiation: 1.8 – 2.3 kg
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent area of untreated skin
Amount / concentration applied:
- Total volume applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test article was applied undiluted.
- Area of exposure: The test substance was applied to a gauze patch (2.5 cm x 2.5 cm). The patch was placed on the appropriate test field. A strip of aluminium foil was placed over the treated site and the whole trunk was wrapped with an elastic adhesive bandage.
- Occlusion: semi-occlusion
- Vehicle: none
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: After 4 hours exposure the bandage and patch were taken off and the test substance was removed by gentle swapping of the skin with cotton wool soaked in water at approximate body temperature.
EXAMINATIONS
- Scoring system: according to OECD 404
- Examination time points: Skin reactions were read immediately and 1, 24, 48 and 72 hours as well as 7 and 14 days after the end of the exposure period
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation after 7 d, reversible after 14 d
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation reversible after 14 d
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks:
Desquamation reversible after 14 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: desquamation
Basis:
other: all animals
Time point:
other: day 7
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
No irritation was observed in any animal approximately 1 hour following the 4 hour period of exposure. Very slight erythema (score of 1) was observed in all animals at the subsequent 24 and 48 hour examinations, remaining in 2 animals at the 72 hour examination. Desquamation was noted in all 3 animals after 7 days. Recovery had occurred within 14 days.
Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.
Executive summary:

The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.

Endpoint:
skin corrosion: 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
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye
Amount / concentration applied:
- Amount of substance instilled: 0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 ml
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: Ocular reactions were assessed. After 24 h exposure the eyes were examined additionally after instillation of Fluorescein and irrigation with 20 ml 0.9% sodium chloride solution using UV light.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned
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:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 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
Irritant / corrosive response data:
Well defined conjunctival redness, chemosis and ocular discharge in all three animals one hour after application which remained in one animal at the 24 hours examination. In the remaining two animals slight redness, chemosis and discharge were oserved at the 24 hour reading. At the 48 hour examination only slight conjunctival redness was observed in two animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.
Executive summary:

The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results of the skin irritation study according to OECD 404 indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect on the skin of the rabbit. However, this was not of sufficient severity to require classification of the test item.

The results of the eye irritation study according to OECD 405 indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

According to the classification criteria of regulation (EC) 1272/2008 2 -butyloctanoic acid has not to be classified neither as skin irritant nor eye irritant.