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Diss Factsheets

Administrative data

Description of key information

Skin, rabbit (OECD 404): not irritating

Eye, rabbit (OECD 405): not irritating

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:
31 Aug 2004 - 27 Sep 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
yes
Remarks:
lack of details (test substance, animals, housing, methods)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing with one animal
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
December 29th, 1992
GLP compliance:
yes (incl. QA statement)
Remarks:
Groupe Interministeriel des produits chimiques, Paris, Republique Francaise
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not stated
- Weight at study initiation: 2.32 kg - 2.56 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: not stated
- Water: not stated
- Acclimation period: 7-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 60-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

IN-LIFE DATES: 31 Aug 2004 - 04 Sep 2004
Type of coverage:
semiocclusive
Preparation of test site:
other: not specified;
Remarks:
undamaged skin area of the right flank
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): as supplied by sponsor

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: Right flank. Size of skin area not specified.
- % coverage: not stated
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated

OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the patch

SCORING SYSTEM:
Erythema and Eschar formation: grading scales 0 to 4 (no, slight, definite, moderate, severe)
Oedema: grading scales 0 to 4 (no, slight, slight with contour, moderate, severe)
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No cutaneous reactions (erythema and oedema) were observed at any examination time in any of the three animals.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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:
06 Sep 2004 - 27 Sep 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
yes
Remarks:
lack of details (test substance, animals, housing, methods)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
no rationale for in vivo testing, no initial testing with one animal, no topical anesthetics
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not stated
- Weight at study initiation: 2.23 kg - 2.43 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: not stated
- Water: not stated
- Acclimation period: 6-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 65-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

IN-LIFE DATES: 06 Sep 2004 - 11 Sep 2004
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: as supplied by sponsor
Duration of treatment / exposure:
Single instillation into one eye
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Ocular examinations were performed on both eyes 1, 24, 48 and 72 hours after instillation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
- Time after start of exposure: not stated

SCORING SYSTEM:
Chemosis: 0-4
Conjunctiva Redness: 0-3
Iris: 0-2
Cornea opacity: 0-4
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean over
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
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A skin irritation GLP study according to OECD guideline 404 (key study, 2004) was performed with Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3). 0.5 mL of the undiluted test substance as supplied by the sponsor was applied to the undamaged right flank of 3 female New Zealand White rabbits for 4 hours of exposure under semi-occlusive conditions. The local skin effects were scored 1, 24, 48, and 72 h after exposure had ended.

The mean erythema and oedema scores (over 24, 48 and 72 hours) were 0.0 and 0.0. The test substance was not irritating to the skin.

Eye irritation

An eye irritation GLP study according to OECD guideline 405 (key study, 2004) was performed with Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3). 0.1 mL of the undiluted test substance as supplied by the sponsor was instilled into one eye of 3 New Zealand White rabbits. The eyes were scored 1, 24, 48, and 72 h after instillation.

The mean chemosis, cornea opacity, and iris scores (over 24, 48 and 72 hours) were 0.0, 0.0 and 0.0. The mean conjunctivae score (over 24, 48 and 72 hours) was 0.0 in one rabbit and 0.3 in the two other rabbits. Reddening of conjunctivae was fully reversible within 48 hours. The test substance was not irritating to the eye.

Overall conclusion for skin and eye irritation

No skin and no eye irritation potential was shown for Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3).

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.