Registration Dossier
Registration Dossier
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EC number: 810-472-7 | CAS number: 159325-45-8
Toxicological information
Endpoint summary
Administrative data
Description of key information
Epyrron was not irritating to the skin of rabbits but was irritating to the eyes of rabbits at a dosage of 0.5 grams.
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
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: 6 weeks old
- Weight at study initiation: Less than 3.5 kg
- Housing: Individual cages with perforated floors
- Diet: 100 grams/day of standard laboratory rabbit diet (LKK-20 pellet Hope Farms, Woerden, The Netherlands)
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
VEHICLE
- Amount(s) applied (volume or weight with unit): water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal - Flank area
- Coverage: 150 cm squared
- Type of wrap if used: Scotchpak-non-woven of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moistened tissue with tap-water
- Time after start of exposure: 4 Hours
SCORING SYSTEM:
See free text section below. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 Hour
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 Hour
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 Hours
- Score:
- >= 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation or corrosion was reported on rabbits after the exposure to test substance for 4 hours through the duration of the test.
- Other effects:
- No staining of the treated skin area was observed during the test period.
No toxicological symptoms were observed in any of the rabbits exposed to test substance. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results and according to EU criteria the test substance when administered to rabbits at a dosage of 0.5 grams shall not be considered an irritant or corrosive to skin.
Reference
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:
- 3 - 17 November 1997
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: 3.5 kg
- Housing: Individual cages with perforated floors
- Diet: 100 grams per day of standard laboratory rabbit diet (LKK-20, pellet, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48.6 g (approximately 0.1 mL) - Duration of treatment / exposure:
- Single samples were instilled. Remnants of the test substance were present in the eyes of all rabbits up to 48-72 hours after installation.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50 mL of tap-water
- Time after start of exposure: 48 hours
SCORING SYSTEM:
See free text section below
TOOL USED TO ASSESS SCORE: 2% fluorescein in water for 24 hour observation of corneal epithelial damage.
All other examinations were completed using standard lighting or with the assistance of an ophthalmic examination lamp. - Irritant / corrosive response data:
- Effects of irritation were observed within cornea, iris and conjunctivae.
Corneal injury consisted of opacity and epithelial damage (25-35% of corneal area).
Iridic irritation was observed in all rabbits exposed to test substance.
Irritation of conjunctivae consisted of redness, chemosis and discharge in all animals exposed to test substance.
There was no evidence of corrosion. - Other effects:
- Remnants of the test substance were present in the eyes of all animals up to 48-72 hours after exposure.
No symptoms of toxicity were observed during test period, no mortality occurred. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was administered to 3 male rabbits and appears to be irritating to the eye at a dosage of 0.5 grams.
Reference
| Individual Eye Irritation Scores | |||||||
| Animal No. | 1453 | 1479 | 1485 | ||||
| Time after dosing | Tissue Findings | Score | Comments | Score | Comments | Score | Comments |
| 1 hour | Corneal opacity | 0 | D | 0 | D | 0 | D |
| area | 0 | 0 | 0 | ||||
| Iris | 1 | 1 | 1 | ||||
| Conj.: redness | 2(A) | 2(A) | 2(A) | ||||
| Chemosis | 3(A) | 3(A) | 3(A) | ||||
| Discharge | 2 | 2 | 2 | ||||
| 24 Hours | Corneal opacity | 0 | 25 D | 0 | 35 D | 0 | 25 D |
| area | 1 | 2 | 1 | ||||
| Iris | 0 | 1 | 1 | ||||
| Conj.: redness | 3(A) | 3(A) | 3(A) | ||||
| Chemosis | 2(A) | 2(ABC) | 2(ABC) | ||||
| Discharge | 1 | 2 | 2 | ||||
| 48 Hours | Corneal opacity | 1 | D | 1 | D | 1 | D |
| area | 1 | 2 | 1 | ||||
| Iris | 0 | 1 | 0 | ||||
| Conj.: redness | 3(AC) | 3(AC) | 3(AC) | ||||
| Chemosis | 1(ABC) | 2(A) | 2(A) | ||||
| Discharge | 1 | 1 | 1 | ||||
| 72 Hours | Corneal opacity | 0 | 5 | 0 | 25 D | 0 | 5 D |
| area | 1 | 2 | 1 | ||||
| Iris | 0 | 0 | 0 | ||||
| Conj.: redness | 2(AC) | 2(AC) | 3(C) | ||||
| Chemosis | 1(AC) | 1(AC) | 1(ABC) | ||||
| Discharge | 0 | 1 | 1 | ||||
| 7 Days | Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0 |
| area | 0 | 0 | 0 | ||||
| Iris | 0 | 0 | 0 | ||||
| Conj.: redness | 0 | 1(AC) | 1(C) | ||||
| Chemosis | 0 | 0 | 0 | ||||
| Discharge | 0 | 0 | 0 | ||||
| 14 Days | Corneal opacity | 0 | 0 | 0 | |||
| area | 0 | 0 | 0 | ||||
| Iris | 0 | 0 | 0 | ||||
| Conj.: redness | 0 | 0 | 0 | ||||
| Chemosis | 0 | 0 | 0 | ||||
| Discharge | 0 | 0 | 0 | ||||
| () Score given for: A=Eyelids | |||||||
| B=Nictitating membrane | |||||||
| C=Sclera | |||||||
| Comments | |||||||
| D - Remnants of the test substance in the eye | |||||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Epyrron was not irritating to the skin of rabbits but was irritating to the eyes of rabbits at a dosage of 0.5 grams.
.
Justification for selection of eye irritation endpoint:
Epyrron was irritating to the eyes of rabbits at a dosage of 0.5 grams.
Effects on eye irritation: irritating
Justification for classification or non-classification
Epyrron is not classifiable as a skin irritant according to Directive 67/548 EEC or Regulation (EC) 1272/2008 (CLP). However, epyrron is
classified as irritating to the eyes.
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.
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