Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 484-040-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (OECD 404, GLP, K, Rel.2)
Eye irritation: not irritating (OECD 405, GLP, K, Rel.2)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 January to 05 February 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404 with deviations: details on feeding and environmental conditions not reported; isomers ratio not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- directive n° 2004/73/EC
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21
- 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).
- Weight at study initiation: 2.25-2.85 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 30-70 %
- Air changes: No data
- Photoperiod: No data
IN-LIFE DATES: 16 January to 05 February 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied, as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14.
- Number of animals:
- 3 females
- Details on study design:
- PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: Undamaged skin area of the right flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14.
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- - 24 hours after the test item application, on the treated area, a very slight to well definite erythema associated with a very slight to slight oedema was observed.
- The oedematous reactions were totally reversible between the 5th and the 7th day of the test and the erythematous reactions were totally reversible between the 7th and the 8th day of the test.
- On the cutaneous structure, it was recorded a dryness from the 3rd day of the test in 2 animals and from the 5th day of the test in the third animal. The skin recovered a normal aspect between the 11th and the 14th day of the test in two animals but the dryness was still registered the last day of the test (D14) in the last one. - Other effects:
- None
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under these experimental conditions, test item must not be classified according to the CLP Regulation (EC) No. 1272/2008 and classified as "Category 3 (mild irritant)" based on Globally Harmonized System (GHS).
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item was applied on an undamaged skin area of the right flank of 3 female New Zealand White rabbits. On the left flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
It was noted, 24 hours after the test item application, on the treated area, a very slight to well definite erythema associated with a very slight to slight oedema. The oedematous reactions were totally reversible between the 5th and the 7th day of the test and the erythematous reactions were totally reversible between the 7th and the 8th day of the test. On the cutaneous structure, it was recorded a dryness from the 3rd day of the test in 2 animals and from the 5th day of the test in the third animal. The skin recovered a normal aspect between the 11th and the 14th day of the test in two animals but the dryness was still registered the last day of the test (D14) in the last one.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.7 / 2.0 / 2.0 for erythema and 1.0 / 1.7 / 1.7 for oedema.
Under these experimental conditions, test item must not be classified according to the CLP Regulation (EC) No. 1272 /2008 and classified as "Category 3 (mild irritant)" based on Globally Harmonized System (GHS).
Reference
Table 7.3.1/1: Individual and mean skin reactions following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A7944/Female |
A7946/Female |
A7947/Female |
||
Erythema/Eschar formation |
1 h |
1 |
2 |
2 |
24 h |
1 |
2 |
2 |
|
48 h |
2 |
2 |
2 |
|
72 h |
2 |
2 |
2 |
|
Day 4 |
2 |
- |
- |
|
Day 5 |
1 |
- |
- |
|
Day 6 |
0 |
1 |
0 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
5 |
6 |
6 |
|
Mean (24, 48 and 72 hours) |
1.7 |
2.0 |
2.0 |
|
Oedema formation |
1 h |
2 |
2 |
2 |
24 h |
1 |
2 |
2 |
|
48 h |
1 |
2 |
2 |
|
72 h |
1 |
1 |
1 |
|
Day 4 |
0 |
- |
- |
|
Day 5 |
0 |
- |
- |
|
Day 6 |
0 |
0 |
0 |
|
Day 7 |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
3 |
5 |
5 |
|
Mean (24, 48 and 72 hours) |
1.0 |
1.7 |
1.7 |
|
Note:
A7944: dryness from D4 to D14
A7946: slight dryness at D2 & D3 from D10 to D12, dryness from D6 to D9
A7947: slight dryness at D2, D3 & D9, dryness from D6 to D8
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05-14 February 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 405 with deviations: details on feeding and environmental conditions not reported; isomers ratio not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 2004/73/EC
- Deviations:
- yes
- Remarks:
- details on feeding and environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2007-01-11 / Signed on 2007-02-21
- 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).
- Weight at study initiation: 2.19-2.58 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 37-57 %
- Air changes: No data
- Photoperiod: No data
IN-LIFE DATES: 05 to 14 February 2007 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Test item was instilled, as supplied - Duration of treatment / exposure:
- No washing was done
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 4 to 9 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- TREATMENT
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- 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
- Remarks:
- mean individual score
- 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 individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- 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 #2
- Remarks:
- mean individual score
- 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 #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- 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 #3
- Remarks:
- mean individual score
- 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 #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the three animals: a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 10th day of the test, associated with a slight chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 9th day of the test.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item must not be classified according to CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).
- Executive summary:
In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 3 New Zealand White female rabbits were exposed to 0.1 mL of test item in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 4 to 9 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
The conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the three animals: a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between the 3rd and the 10th day of the test, associated with a slight chemosis, noted 1 hour after the test item instillation and totally reversible between the 2nd and the 9th day of the test.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.0, 1.0, 0.3 for conjunctivae score and 1.0, 0.0, 0.0 for chemosis score.
Under the test conditions, test item must not be classified according to CLP Regulation (EC) No. 1272 /2008 and Globally Harmonized System (GHS).
Reference
Table 7.3.2/1: Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit Number and Sex
|
Time After Treatment
|
Corneal Opacity
|
Iris lesion |
Conjunctival Redness
|
Conjunctival Chemosis
|
A7973 Female
|
1 h |
0 |
0 |
2 |
1 |
24 h |
0 |
0 |
1 |
1 |
|
48 h |
0 |
0 |
1 |
1 |
|
72 h |
0 |
0 |
1 |
1 |
|
Day 4 |
0 |
0 |
1 |
1 |
|
Day 5 |
0 |
0 |
1 |
1 |
|
Day 6 |
0 |
0 |
1 |
1 |
|
Day 7 |
0 |
0 |
1 |
1 |
|
Day 8 |
0 |
0 |
1 |
0 |
|
Day 9 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
3 |
3 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
1.0 |
1.0 |
|
A7975 Female
|
1 h |
0 |
0 |
1 |
1 |
24 h |
0 |
0 |
1 |
0 |
|
48 h |
0 |
0 |
1 |
0 |
|
72 h |
0 |
0 |
1 |
0 |
|
Day 4 |
0 |
0 |
1 |
0 |
|
Day 5 |
0 |
0 |
1 |
0 |
|
Day 6 |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
3 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
1.0 |
0.0 |
|
A7978 Female
|
1 h |
0 |
0 |
1 |
1 |
24 h |
0 |
0 |
1 |
0 |
|
48 h |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Total (24, 48 and 72 h) |
0 |
0 |
1 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.3 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study was identified (Phycher, 2007). In this dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 3 female New Zealand White rabbits were exposed for 4 hours to a semi-occluded application of 0.5 mL of undiluted test material to the intact skin. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
It was noted, 24 hours after the test item application, on the treated area, a very slight to well definite erythema associated with a very slight to slight oedema. The oedematous reactions were totally reversible between the 5th and the 7th day of the test and the erythematous reactions were totally reversible between the 7th and the 8th day of the test. On the cutaneous structure, it was recorded a dryness from the 3rd day of the test in 2 animals and from the 5th day of the test in the third animal. The skin recovered a normal aspect between the 11th and the 14th day of the test in two animals but the dryness was still registered the last day of the test (D14) in the last one.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.7 / 2.0 / 2.0 for erythema and 1.0 / 1.7 / 1.7 for oedema.
Eye irritation:
A key study was identified (Phycher, 2007). In this eye irritation study performed according to the OECD guideline 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into one eye of 3 female New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 4 to 9 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 1.0, 1.0, 0.3 for conjunctivae score and 1.0, 0.0, 0.0 for chemosis score.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Skin irritation:
Based on the available data:
- no additional self-classification is proposed regarding skin irritation according to the CLP. However, the supplemental hazard statement, EUH066, should be applied based on the extrapolation of the results of the OECD 404 study, i.e. dryness registered until the last day of the test (D14) in one animal.
- the substance should be classified as "Category 3 (mild irritant)" according to the GHS.
Eye irritation:
Based on the available data, no additional self-classification is proposed regarding eye irritation according to the CLP and to the GHS.
Respiratory irritation:
No data was available regarding respiratory irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
