Registration Dossier
Registration Dossier
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EC number: 607-089-0 | CAS number: 224789-21-3
Endpoint summary
Administrative data
Description of key information
Imidazotriazinon is not irritating to skin and eyes of rabbits.
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:
- Feb 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: 5.5-8.5 months
- Weight at study initiation: 2.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqua ad iniectabilia
- Controls:
- other: the surrounding untreated skin served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: no residual test item had to be removed
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- No systemic intolerance reactions were observed.
- Executive summary:
In a dermal irritation study according to OECD TG 404 the test substance was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 female rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. The mean irritation indices for erythema and edema were 0 of max. 4. No systemic intolerance reactions were observed.
According to classification criteria Imidazotriazinon is not an irritant to the 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:
- Feb 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- 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 g
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- No systemic intolerance reactions were observed.
- Executive summary:
In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 male rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study no irritation effects were seen at cornea, iris and conjunctivae 24 to 72 hours after instillation. No systemic intolerance reactions were observed.
According to classification criteria Imidazotriazinon is not an irritant to the eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Imidazotriazinon was not irritating to the skin of rabbits according to OECD TG 404 (Leuschner, 2000a). No systemic intolerance reactions were observed.
Eye irritation
Imidazotriazinon was not irritating to the eyes of rabbits according to OECD TG 405 (Leuschner, 2000b). No systemic intolerance reactions were observed.
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
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.
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