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Registration Dossier
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EC number: 219-034-4 | CAS number: 2322-77-2
Endpoint summary
Administrative data
Description of key information
Skin irritation (rat): not irritating [Draft report, Kurth 1996]
Eye irritation (rabbit): not irritating [Draft report, Treher 1996]
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:
- June to July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to 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)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- - exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- Principles of method if other than guideline:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- other: Han: WST (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: 106-118 g (males) and 95-111 g (females)
- Fasting period before study: ca. 19 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 900 mg NaCl ad 100 ml bidist. water
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 212-236 mg/male animal or 190-222 mg/female animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- OBSERVATION TIME POINTS
Body weight and other observations were performed at day 1, 7 and 14. - Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg (212-236 mg/male and 190-222 mg/female applied as a paste) was tolerated without any local irritations.
- Executive summary:
In a primary dermal irritation study similar to OECD TG 404, (young adult) Wistar rats, female and male (3/sex) were dermally exposed to 212-236 mg/male animal or 190-222 mg/female animal of D-ET-Dienon in physiological saline for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to the system recommended in Directive 67/548/EEC.
No local irritations were observed. In this study, the test item is not a dermal irritant.
Reference
All animals without any local irritations (no further data available).
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:
- August 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- 4 animals (2M, 2F)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 3.1 kg (males), 2.9-3.1 kg (females)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 56-60%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- before application, 0.5; 1 and 2 hours thereafter and then every 24 hours until day 8 of the test
- Number of animals or in vitro replicates:
- 2 females, 2 males
- Details on study design:
- 0.1 mL corresponded to 63-64 mg substance.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: No washing
SCORING SYSTEM: Evaluation of the local tolerance on the conjunctiva of the rabbit after a single application was performed according to the score system recommended for the EU.
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a local tolerance test on the rabbit eye similar to OECD TG 405 a single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to day 7. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling. With regard to conjunctival reddening 2/4 animals showed a mean score of 1 and 1.33 .
- Executive summary:
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 63-64 mg of D-ET-Dienon was instilled into the conjunctival sac of the right eye of young adult female and male New Zealand White rabbits (2/sex) and the animals were observed for 8 daysThe eyes were not washed. Irritation was scored by the method described in the guideline.
A single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to day 7. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling. With regard to conjunctival reddening 2/4 animals showed a mean score of 1 and 1.33. In this study, the test item is not an eye irritant.
Reference
Table 1: Results of the study
Irritant effects (score) | |||||
Animal no. (sex) | Irritation parameter | 24 h | 48 h | 72 h | Mean scores |
1 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
2 (M) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 2 | 1 | 1 | 1.33 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
| 4 (F) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0 | |
The control eyes were without findings.
A single application of 0.1 ml of the test item into the conjunctival sac of the rabbit eye led to slight to moderate secretion, reddening and swelling of the outer eyelids and eyelid closure mainly on days 1-2. Additionally, reddening and swelling of the conjunctivae were observed which were slight to moderate up to day 2, while slight conjunctival reddening and/or vascular injection were observed up to day 7. One animal was without findings on day 2, while the other animals were without findings on days 7 or 8.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study similar to OECD TG 404, (young adult) Wistar rats, female and male (3/sex) were dermally exposed to 212-236 mg/male animal or 190-222 mg/female animal of D-ET-Dienon in physiological saline for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to the system recommended in Directive 67/548/EEC.
No local irritations were observed. In this study, the test item is not a dermal irritant.
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 63-64 mg of D-ET-Dienon was instilled into the conjunctival sac of the right eye of young adult female and male New Zealand White rabbits (2/sex) and the animals were observed for 8 daysThe eyes were not washed. Irritation was scored by the method described in the guideline.
A single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to day 7. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling. With regard to conjunctival reddening 2/4 animals showed a mean score of 1 and 1.33. In this study, the test item is not an eye irritant.
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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