Registration Dossier
Registration Dossier
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EC number: 608-209-4 | CAS number: 284461-73-0
Endpoint summary
Administrative data
Description of key information
BAY 43-9006 was not irritating to the skin of rabbits according to OECD TG 404 (Schüngel, 2004a). No systemic intolerance reactions were observed.
BAY 43-9006 was slightly irritating to the eyes of rabbits according to OECD TG 405 (Schüngel, 2004b). In all animals, redness of conjunctivae was fully reversible within 3 days. No relevant systemic intolerance reactions were observed.
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:
- Sep 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.1-3.7 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 60 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test substance moistened with aqua p.i.
- Controls:
- other: the contralateral untreated skin area 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. 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: exposed skin area was carefully washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- No systemic intolerance reactions were observed.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a dermal irritation/corrosion 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 BAY 43-9006 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:
- Sep 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.2-3.8 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 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:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- iris score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score after 72 hours: 0.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: mean score after 72 hours: 1.0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2,3
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: mean score after 72 hours: 0.3
- Irritant / corrosive response data:
- Redness of conjunctivae (grade 1) was observed in all animals 1 hour after instillation. At that time point chemosis of conjunctivae (grade 1) was observed in two animals. The fluorescein test performed after 24 hours revealed no corneal effects.
- Other effects:
- No relevant systemic intolerance reactions were observed.
- Interpretation of results:
- GHS criteria not met
- 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 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study BAY 43-9006 shows slight irritant effects (mean irritation index for conjunctivae score = up to 1.0 of max. 3) which were fully reversible within 3 days. No irritation effects were registered for cornea, iris and conjunctival chemosis 24 to 72 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.
According to classification criteria BAY 43-9006 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
In a dermal irritation/corrosion 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 BAY 43-9006 is not an irritant to the skin (Schüngel, 2004a).
Eye irritation
In an eye irritation study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study BAY 43-9006 shows slight irritant effects (mean irritation index for conjunctivae score = up to 1.0 of max. 3) which were fully reversible within 3 days. No irritation effects were registered for cornea, iris and conjunctival chemosis 24 to 72 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed. According to classification criteria BAY 43-9006 is not an irritant to the eyes (Schüngel, 2004b).
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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