Registration Dossier
Registration Dossier
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EC number: 614-283-9 | CAS number: 68127-59-3
Endpoint summary
Administrative data
Description of key information
Skin irriration, rabbit: slightly irritating, method similar to OECD 404, Southwood 1984a
Eye irriration, rabbit: moderately irritating, method similar to OECD 405, Southwood 1984a
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:
- 1984-01 to 1984-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- animal room temperature slightly low (16°C); purity of the test material not reported.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 3.43 - 3.75 kg
- Housing: individually in satinised aluminium sheet cages, 605 x 490 x 455 mm; floor: perforated aluminium sheet, door: Makrolon (polycarbonate)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 16°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not reported - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 500 mg, moistened to a paste with water
- Test site: approx. 25 x 25 mm on the left flank of the animal
- Application: by disposable spatula
VEHICLE
- Amount applied (volume or weight with unit): 0.5 mL
- Purity: distilled - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 25, 45 and 69 hours after removal of dressing
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Area of exposure: 25 x 25 mm
- % coverage: not reported
- Type of wrap if used: a piece of surgical gauze (25 x 25 mm, 8-ply) covering the treated area was secured by two strips of surgical tape (12 x 100 mm), and covered with 0.5 mm rubber sheeting (350 x 135 mm), which was wrapped around the trunk and secured with adhesive polyethylene tape (450 x 75 mm).
REMOVAL OF TEST SUBSTANCE
- Washing: application site cleansed with swabs of absorbent cotton wool soaked in warm water, gently dried with tissue paper
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Draize scale, as in OECD 404
- Mean erythema and edema scores were calculated as the average of the 25-, 45- and 69-hour readings of all six animals - Irritation parameter:
- erythema score
- Basis:
- other: animal 7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 7
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 8
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 23
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 23
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 24
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 24
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 46
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 46
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 47
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 47
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slightly irritant to rabbit skin, no corrosion observed . Erythema and edema reversible.
- Other effects:
- None observed
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Slight erythema and slight edema was caused by the test material on rabbit skin, 25 hours after the treatment (mean score 0.11, both for erythema and edema). The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labelling.
- Executive summary:
The acute skin irritation of the test material (a powder) was assessed according to a method similar to OECD 404 in six female New Zealand White rabbits. The test substance (0.5 g) was moistened with 0.5 mL deionized water and applied to the shaved skin (approx. 6 cm2), then covered with a gauze patch and semi-occlusive dressing for an exposure period of 4 hours. The application area was then cleansed with cotton wool swabs soaked in warm water, and dried with tissue paper. The degrees of erythema and edema were assessed at the following time points: 1, 25, 45, and 69 hours after the removal of the patch, according to the Draize scale. Mean erythema and edema scores were calculated from the readings at 25, 45, and 69 hours.
Very slight to well-defined erythema, and very slight to moderate edema were observed after 1 hour; these findings were still seen in only 2/6 animals at 25 hours, and completely disappeared at 45 hours. From the numerical scores of the individual animals at 25, 45, and 69 hours, the averages for erythema and edema were calculated to be 0.11 each.
Reference
Table 1: Rabbit skin irritation
Erythema & edema: Draize scores for individual animals:
| Erythema | Edema | |||||||
Animal no |
Hours after decontamination | Hours after decontamination | ||||||
| 1 | 25 | 45 | 69 | 1 | 25 | 45 | 69 | |
| 7 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| 8 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| 23 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
| 24 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 46 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 |
| 47 | 2 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
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:
- 1984-01 to 1984-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period limited to 7 days, in spite of slight conjunctival redness + discharge on day 7; animal room temperature slightly low (16°C); purity of test material not reported.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.76 - 3.61 kg
- Housing: individually in satinised aluminium sheet cages, 605 x 490 x 455 mm; floor: perforated aluminium sheet, door: Makrolon (polycarbonate)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 16°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not reported - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): approx. 100 mg solid test substance / test eye (left eye)
- Application into the conjunctival sac of the left eye
- Concentration (if solution): not applicable
VEHICLE
- none - Duration of treatment / exposure:
- - Lids of treated eye gently held together for 1-2 seconds
- 3 / 9 animals: irrigation of treated eye after 20 - 30 seconds - Observation period (in vivo):
- 1 - 2 hours, 1, 2, 3, 4, and 7 days after application
- Number of animals or in vitro replicates:
- 9 male rabbits, thereof 3 with eye irrigation shortly after application
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals: washing with 200 mL clean lukewarm water
- Time after start of exposure: 20 - 30 seconds after application of test substance
- No washing in 6 animals
SCORING SYSTEM:
- Draize scale for scoring ocular lesions:
Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics, Association of Food and Drug Officials of the US, 46.
- Interpretation / classification of numerical scores:
Kay JH & Calandra JC (1962) J. Soc. Cosmet. Chem. 13: 6 (modified, as documented in appendix 6 of the study)
TOOL USED TO ASSESS SCORE: none reported
INITIAL PAIN REACTION:
- Assessed immediately after application
- Scale 0 - 5 points, depending on observed reactions, according to descriptions shown in appendix 4 of report - Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritant / corrosive response data:
- Slight iritis and slight corneal opacity were observed in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
- Other effects:
- Initial pain reaction: practically none to moderate (classes 1-3 on a 0-5 scale)
Slight mucoid discharge and slight Harderian discharge on day 3 in one animal each - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The irritant potential of the test substance to the rabbit eye was found to be moderate (class 5 on a 1-8 scale) without irrigation, and mild (class 4) after irrigation. The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.
- Executive summary:
The acute eye irritation potential of the test material (a powder) was assessed according a method similar to OECD 405 in nine male New Zealand White rabbits. The test substance (0.1 g) was applied directly into the conjunctival sac of the left eye of the animals; the right eye served as control. The eyes of three rabbits were irrigated with 200 mL of lukewarm water 20-30 seconds after the application. The ocular reactions were assessed at the following time points: 1-2 hours, 1, 2, 3, 4, and 7 days post application, according to the Draize scale.
Practically none to moderate initial pain was observed immediately after the application of the test substance.
Slight iritis and slight corneal opacity were recorded in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
Reference
One animal in the non-irrigated group became sick and had to be killed on day 6 after the application; it still showed conjunctival discharge. Another one (with irrigated eye) was found dead on day 3, with slight redness, chemosis, and discharge. The author does not attribute the deaths to effects of the test material.
Table 1: Data for individual animals without irrigation:
| Animal | Sex | Elapsed | Cornea | Iris | Conjunctiva | Total | ||||||
| no | time | Opacity | Area | Score | Score | Redness | Chemosis | Discharge | Score | Score | ||
| (A) | (B) | (AxBx5) | (C) | (Cx5) | (D) | (E) | (F) | (D+E+F)x2 | ||||
| 15 | M | 1.4 hrs | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 3 | 14 | 19 |
| 1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 1 | 10 | 15 | ||
| 2 days | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 1 | 8 | 13 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 16 | M | 1.5 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
| 1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 2 | 12 | 17 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
| 17 | M | 1.4 hrs | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 3 | 14 | 19 |
| 1 day | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 10 | 10 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 6 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
| 6 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
| 18 | M | 1.4 hrs | 1 | 1 | 5 | 1 | 5 | 2 | 2 | 3 | 14 | 24 |
| 1 day | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 2 | 10 | 15 | ||
| 2 days | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 2 | 10 | 15 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 19 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
| 1 day | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
| 20 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
| 1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 1 | 10 | 15 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 4 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
Table 2: Data for individual animals with irrigation:
| Animal | Sex | Elapsed | Cornea | Iris | Conjunctiva | Total | ||||||
| no | time | Opacity | Area | Score | Score | Redness | Chemosis | Discharge | Score | Score | ||
| (A) | (B) | (AxBx5) | (C) | (Cx5) | (D) | (E) | (F) | (D+E+F)x2 | ||||
| 12 | M | 1.3 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 |
| 1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 1 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 13 | M | 1.5 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 |
| 1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
| 3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
| 4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
| 7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 14 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 |
| 1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
| 2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
One skin irritation study conducted under GLP according to method similar to guideline OECD 404 (with minor deviations) is available (Southwood 1984a). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling.
Very slight to well-defined erythema, and very slight to moderate edema were observed after 1 hour; these findings were still seen in only 2/6 animals at 25 hours, and completely disappeared at 45 hours. From the numerical scores of the individual animals at 25, 45, and 69 hours, the averages for erythema and edema were calculated to be 0.11 each.
Eye
One eye irritation study conducted under GLP according to a method similar to guideline OECD 405 is available (Southwood 1984a). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling.
Practically none to moderate initial pain was observed immediately after the application of the test substance.
Slight iritis and slight corneal opacity were recorded in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
The available data on Skin Corrosion/Irritation is considered adequate for the classification and labelling.
Based on the result, the substance does not meet the criteria for classification under the Directive 2001/59/EC, Annex VI, 3.2.6.1. as well as the criteria in the Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2.
The available data on Eye Irritation is considered reliable and suitable for classification and labelling.
Based on the result, the substance does not meet the criteria for classification under the Directive 2001/59/EC, Annex VI, 3.2.6.2. as well as the criteria in the Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.3.2.
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