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EC number: 429-900-5 | CAS number: 82356-51-2
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- Endpoint summary
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: not irritating (OECD 404, GLP, K, rel. 1).
Eye irritation: not irritating (OECD 405, GLP, K, rel. 1).
Respiratory irritation: no study available.
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:
- From 1991-07-09 to 1991-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 and in compliance with GLP with minor deviations (age of animals at study initiation not reported). Except for this minor deviation, the study was fully reliable.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP (inspection date: 1990-06-19 / signature date: 1990-10-05)
- Specific details on test material used for the study:
- - Lot/batch No.: A/S/31635 (lab code)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex.
- Age at study initiation: no data
- Weight at study initiation: 2.6-3.0 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C. On 3 occasions the temperature exceeded this range by 1°C.
- Humidity (%): 59-69 % with the exception of one occasion when a value of 76 % relative humidity was recorded.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after patch removal. Additional examination on day 7.
- Number of animals:
- 4 animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square (6.25 cm2)
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale according to OECD guideline No. 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- 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:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- One hour after the end of the dosing period, erythema varying in degree from slight to well defined was apparent in all 4 rabbits and very slight oedema was noted in 2 of the 4 animals.
24 hours after patch removal erythema and oedema were observed in all 4 rabbits.
At the 72 hour assessment, irritation has entirely subsided in 2 animals. Erythema was slight to moderate in the remaining 2 rabbits.
7 days after the dosing, erythema and oedema were no longer apparent in any of the animal although skin thickening was noted in one of them. - Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induced a slight irritation being largely reversible within 7 days of dosing.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) as scores were below 2.3 and to the GHS as only 2 animals out of 4 had scores between 1.5 and 2.3. - 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 material was dermally applied on the shaved skin of the dorsal surface of the trunk of 4 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 7 days for oedema and erythema.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch and on day 7.
The mean scores over all the animals tested within 3 scoring times (24, 48 and 72 hrs) were 2.0/0.7/0.3/2.7 for erythema and 1.3/0.7/0.3/1.3 for oedema.
Under the test conditions, the test material induced a slight irritation being largely reversible within 7 days of dosing.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) as scores were below 2.3 and to the GHS as only 2 animals out of 4 had scores between 1.5 and 2.3.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
Reference
Table 7.3.1/1: Irritant/corrosive response data at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
2/2/2/1 |
1/0/1/0 |
24 h |
1/1/1/2 |
2/1/1/1 |
48 h |
2/1/0/3 |
1/1/0/1 |
72 h |
3/0/0/3 |
1/0/0/2 |
Average 24h, 48h, 72h |
2/0.7/0.3/2.7 |
1.3/0.7/0.3/1.3 |
Reversibility*) |
c |
c |
Average time (day) for reversion** |
7 days |
7 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
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:
- From 1991-08-20 to 1991-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 405 and in compliance with GLP with minor deviations (age of animals at study initiation not reported). Except for this minor deviation, the study was fully reliable.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation not reported
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspection date: 1990-06-19 / signature date: 1990-10-05)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex.
- Age at study initiation: no data
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC Stanrab, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C.
- Humidity (%): 59-69 % with the exception of one occasion when a value of 76 % relative humidity was recorded.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- The eye was not rinsed after the instillation of the test item.
- Observation period (in vivo):
- Examination made 1, 24, 48 and 72 hours following instillation
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize scale according to the OECD guideline No. 405
TOOL USED TO ASSESS SCORE: standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour) - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1 and #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- 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:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour after dosing, some discharge and chemosis and definite conjunctival redness (grade 2-3) were noted in all 4 animals. Between 24 and 48 hours the irritation was reduced with only slight chemosis and/or redness in some animals. At 72 hours, no signs of irritation were detected in any animals. No corneal or iridial irritation occurred in any animal during the study.
- Other effects:
- No other effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and of the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 4 female New Zealand White Rabbits. The eyes were not rinsed after the instillation of the test item. The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
The calculated mean score for each individual lesion for all animals within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.3 for chemosis; 0.4 for redness; 0.0 for discharge, iris and corneal lesions.
The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7/0.0/0.0/0.3 for chemosis; 0.7/0.3/0.0/0.7 for redness; 0/0/0/0 for discharge, iris and corneal lesions.
The effects observed were all reversible within 72 hours.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 7.3.2/1: Mean irritant/corrosive response data of 4 animals at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0 |
0 |
0 |
2.25 |
1.50 |
1.25 |
24 h |
0 |
0 |
0 |
0.75 |
0.50 |
0 |
48 h |
0 |
0 |
0 |
0.50 |
0.25 |
0 |
72 h |
0 |
0 |
0 |
0.00 |
0.00 |
0 |
Reversibility*) |
- |
- |
- |
c. |
c. |
c. |
Average time (unit) for reversion |
- |
- |
- |
72 h |
72 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 7.3.2/2: Individual irritant/corrosive response data at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
3 / 2 / 2 / 2 |
2 / 1 / 1 / 2 |
1 / 1 / 1 / 2 |
24 h |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
1 / 1 / 0 / 1 |
1 / 0 / 0 / 1 |
0 / 0 / 0 / 0 |
48 h |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
1 / 0 / 0 / 1 |
1 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
72 h |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
Average 24h, 48h, 72h |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 |
0.7 / 0.3 / 0.0 / 0.7 |
0.7 / 0.0 / 0.0 / 0.3 |
0 / 0 / 0 / 0 |
Reversibility*) |
- |
- |
- |
c. |
c. |
c. |
Average time (unit) for reversion |
- |
- |
- |
72 h |
72 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
A key study was identified (Toxicol, 1992, rel. 1). This dermal irritation study was performed according to the OECD guideline No. 404, and in compliance with GLP. The mean scores over all the 4 animals tested within 3 scoring times (24, 48 and 72 hrs) were 2.0/0.7/0.3/2.7 for erythema and 1.3/0.7/0.3/1.3 for oedema. Under the test conditions, the substance induced a slight irritation being largely reversible within 7 days of dosing and therefore does not require classification for skin irritation.
Eye irritation:
A key study was identified (Toxicol, 1992, rel. 1). This eye irritation study was performed according to the OECD guideline No. 405, and in compliance with GLP. The calculated mean score for each individual lesion for all 4 animals within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.3 for chemosis; 0.4 for redness; 0.0 for discharge, iris and corneal lesions. The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7/0.0/0.0/0.3 for chemosis; 0.7/0.3/0.0/0.7 for redness; 0/0/0/0 for discharge, iris and corneal lesions. The effects observed were all reversible within 72 hours. The substance does not require classification for eye irritation.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information, no additional self-classification is proposed regarding both skin and eye irritation according to the CLP as scores were below 2.3 and to the GHS as only 2 animals out of 4 had scores between 1.5 and 2.3.
Based on the available information, no additional self-classification is proposed regarding eye irritation according to the CLP and to the GHS.
No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.
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