Registration Dossier
Registration Dossier
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EC number: 237-249-1 | CAS number: 13708-85-5
Toxicological information
Endpoint summary
Administrative data
Description of key information
The substance was shown to be neither irritating to skin nor to eyes in in-vivo tests accoring to the respective OECD guidelines.
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:
- 04/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 2 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wetted cloth
- Time after start of exposure: 4 hours
SCORING SYSTEM:
< 2points: mild irritant
2 to 5 points: medium irritant
> 5 points: severe irritant - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation observed at any animal at any time point.
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the experimental data, there is no need for classification according to (EU) No. 1272/2008.
- Executive summary:
No irritating properties of the substance could be detected in a skin irritation study according to OECD 404.
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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 to 3.2 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
0 - 10: non irritant
11 - 25: slightly irritant
26 - 56: moderately irritant
57 - 110: severely irritant - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritant / corrosive response data:
- The animals showed deviations from normal findings over a period of 2 days. Within this period, redness was observed. Within the 24 hours after the application, increased secretion were observed. No findings at cornea and iris were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results, there is no need for classification according to (EU) No. 1272/2008.
- Executive summary:
Slight symptoms of irriation (redness, secretion) were observed within a period of 2 days after the application of the substance. All symptoms were fully reversible within 7 days
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Valid test according to OECD criteria under GLP conditions
Justification for selection of eye irritation endpoint:
Valid test according to OECD criteria under GLP conditions
Valid test according to OECD criteria under GLP conditions
Justification for selection of eye irritation endpoint:
Valid test according to OECD criteria under GLP conditions
Justification for classification or non-classification
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.
