Registration Dossier
Registration Dossier
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EC number: 248-948-6 | CAS number: 28299-41-4
Endpoint summary
Administrative data
Description of key information
In 2 valid skin irritation studies, ditolylether was found as
slight/moderately irritating (Maertins, Suberg) to the skin, whereas a
study with a semiocclusive application of the test substance over 24
hours at the inside of a rabbit ear found the test item highly
irritating to the skin.
2 valid eye irritation studies stated ditolylether as not irritating to
the eye (Maertins, Thyssen).
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)
- Rationale for reliability incl. deficiencies:
- other: guideline study according OECD 404
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- 3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythema, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- White New Zealand rabbits, weight 2.9 to 3.3 kg; husbandry: standardized conventional conditions in individual stainless steel cages.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount: 500 µl
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Method: 3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days
Result: slightly irritating to the skin, but not sufficient for classification
Reference: Maertins (Bayer AG), 1989
Reference
No data
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study according OECD 405
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. The other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- White New Zealand rabbits, weight 3.1 to 3.2 kg; husbandry: standardized conventionel conditionsin individual stainless steel cages.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 µl/undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: as described by Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Method: 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. the other eye remained untreated and served as control. the treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound
Result: not irritating to the eye
Reference: Maertins (Bayer AG), 1989
Reference
This study reveals that the test substance does not have a significant irritant potential on the eye.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two valid studies conducted according to OECD TG 404 found ditolyl ether to be not irritating according to GHS criterias. A study following no guideline (24 h application, inside rabbit ear) reported irritating observations of ditolylther but this method is known to overestimate potential skin irritating effects.
In 2 valid studies ditolylether was not irritating to the eye.
Justification for classification or non-classification
The findings for skin irritation did not meet the criteria for classification. Also for eye irritation a classification is not required.
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