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EC number: 235-045-7 | CAS number: 12061-16-4
Endpoint summary
Administrative data
Description of key information
Skin Irritation
One key study is provided. No signs of dermal irritation were observed.
Eye Irritation
One key study is provided. No signs of ocular irritation were observed.
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:
- 5 November 1990 - 8 November 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FHSA 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Acclimation period: 12 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C
IN-LIFE DATES: From: 5 November 1990 To: 8 November 1990 - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test material was placed on each of the test sites (i.e. abraded and intact skin).
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours. Evaluation occurred 24 and 72 hours after exposure.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm² (two per rabbit, one intact and one abraded).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently wiped clean of any residual test material.
- Time after start of exposure: after 24 hours of exposure.
SCORING SYSTEM:
Erythema and eschar formation:
0: No erythema:
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading
Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (edges raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean at 24 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean at 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean at 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean at 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- All sites were clear of irritation during the test period.
- Other effects:
- All animals appeared active and healthy.
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
- Executive summary:
The primary skin irritation potential of the test material was investigated in a study which was broadly conducted in accordance with the FHSA guideline 16 CFR 1500.41.
During the study 0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure.
All sites were clear of irritation during the test period and the Primary Dermal Irritation Index was 0.0.
Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
Reference
Table 1 Primary Dermal Irritation (PDI) Scores - Individual Results
Rabbit |
24 hours |
72 hours |
||
Abraded |
Intact |
Abraded |
Intact |
|
7740 7741 7742 7743 7744 7745 |
0/0 0/0 0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
Total |
0/0 |
0/0 |
0/0 |
0/0 |
Mean |
0/0 |
0/0 |
0/0 |
0/0 |
Key: erythema and eschar / oedema
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:
- 13 November 1990 - 16 November 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FHSA 16 CFR 1500.42
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
IN-LIFE DATES: From: To: 25 October 1990 - 16 November 1990 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Duration of treatment / exposure:
- Three of the treated eyes were rinsed 30 seconds post-installation.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6; 3 male, 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): three of the treated eyes were rinsed with 30 cc of saline solution.
- Time after start of exposure: 30 seconds post-exposure.
- Scoring system: according to the method of Draize. Ocular lesions were evaluated at 24, 48 and 72 hours post installation. Fluorescein was used at the 24 hour evaluation.
Draize Scale for Scoring Ocular Irritation
1. CONJUNCTIVAE
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3
(B) Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4
(C) Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
(D) Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
(E) Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4
(F) Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110 - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- iris score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7806
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7807
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7808
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7809
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7810
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7811
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- -No corneal opacity was noted in any of the treated eyes.
-Iritis was observed in two unwashed eyes 24 hours post installation and in one eye at 48 hours. By 72 hours all eyes were free of iritis. Iritis was not observed in any of the washed eyes.
-Conjunctival irritation was noted in all eyes 24 and 48 hours after administration. This remained in one unwashed and two washed eyes after 72 hours. - Other effects:
- All animals appeared active and healthy. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed.
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes.
- Executive summary:
The eye irritation potential of the test material was investigated in a study which was broadly conducted in accordance with FHSA guideline16 CFR 1500.42. During the study 0.1 g of the test material was instilled into the left eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for three days and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize.
Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes. No classification is required in accordance with EU criteria.
Reference
Table 1 Individual Results
Time Point (hours) |
Rabbit Number |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
24 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
1 0 1 0 0 0 |
2 2 2 2 1 1 |
2 1 1 1 1 1 |
3 2 2 1 2 1 |
48 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
0 0 1 0 0 0 |
1 2 1 1 1 2 |
1 1 0 1 1 1 |
1 0 0 0 0 0 |
72 |
7806 7807 7808 7809 7810 7811 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 1 0 0 0 1 |
0 1 0 0 1 1 |
0 0 0 0 0 0 |
Rabbits 7809, 7810 and 7811 had the treated eye rinsed with 30 cc of saline solution 30 seconds post-installation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
The primary skin irritation potential of the test material was investigated in a study which was broadly conducted in accordance with the FHSA guideline 16 CFR 1500.41. During the study 0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure. All sites were clear of irritation during the test period and the Primary Dermal Irritation Index was determined to be 0.0.
Under the conditions of this study, the test material was not irritating to skin and requires no classification in accordance with the EU criteria.
Eye Irritation
The eye irritation potential of the test material was investigated in a study which was broadly conducted in accordance with FHSA guideline16 CFR 1500.42. During the study 0.1 g of the test material was instilled into the left eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for three days and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize.
Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes. No classification is required in accordance with EU criteria.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
The key study was conducted broadly in accordance with the FHSA guideline 16 CFR 1500.41. This reference does not provide a full report with regard to the methods used in this study. However, as most basic key information is reported, the study can be judged as scientifically acceptable. As such, it was awarded a reliability score of 2 in accordance with the criteria of Klimisch (1997).
Justification for selection of eye irritation endpoint:
Only one study available.
The key study was conducted broadly in accordance with the FHSA guideline 16 CFR 1500.42. This reference does not provide a full report with regard to the methods used in this study. However, as most basic key information is reported, the study can be judged as scientifically acceptable. As such, it was awarded a reliability score of 2 in accordance with the criteria of Klimisch (1997).
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for irritation or corrosion to either the skin or eye.
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