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Registration Dossier
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EC number: 200-658-0 | CAS number: 67-52-7
Endpoint summary
Administrative data
Description of key information
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48, 72 hours and 7 days after removal of the dressing. No signs of corrosion/irritation were observed at any reading time. The test item therefore has to be regarded as not irritating to skin.
A study with the test item according to OECD Guideline 405 was performed to investigate the irritation potential to the rabbit eye.
The test item caused slight reactions of conjunctivae and corneae of the animals. Additionally, eye discharge was observed in the animals one hour after treatment until 72 h. 7 days after treatment all signs of irritation were fully reversible.
Testing of barbituric acid for primary eye irritation in the rabbit showed that the substance has not to be regarde as irritating to the eye.
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:
- guideline study
- Remarks:
- Well performed GLP and OECD guideline study
- Reason / purpose for cross-reference:
- reference to same study
- 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:
- - Animal specifics: strain HC
- Age at study initiation: adult
- Weight at study initiation: 3,4 kg to 3,9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (Ssniff K 4) Appr. 100 -120 g once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 times - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: hypoallergenic patch (Beiersdorf AG)
A further patch serving as control was moistened with water and placed on the opposite dorso-lateral areas of the trunk of each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Irritant / corrosive response data:
- no signs of irritation at any time
- Other effects:
- no other effects reported
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- Based on the findings in this study the test item has to be regarded as not irritating to skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48, 72 hours and 7 days after removal of the dressing. No signs of corrosion/irritation were observed at any reading time. The test item therefore has to be regarded as not irritating to 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well performed GLP and OECD guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: strain HC
- Age at study initiation: adult
- Weight at study initiation: 2,7 kg to 3,8 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: standard laboratory diet (Ssniff K 4) Appr. 100 -120 g once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 times - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL equivalent to approx. 60 mg - Duration of treatment / exposure:
- Single administration
Exposure period: 24 hours after instillation of the test substance the treated eye was rinsed with saline - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the substance to the conjunctival sac of one eye of each animal, the other eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after instillation of the test substance the treated eye was rinsed with saline.
TOOL USED TO ASSESS SCORE: 1 % solution of fluorescein, under UV light - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no signs of irritation (conjunctivae) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- discharge was observed from 1 until 72 h after application.
All signs of irritation were fully reversible within 7 days. - Other effects:
- No other effects reported.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- Testing of barbituric acid for primary eye irritation in the rabbit showed that the substance has not to be regarde as irritating to the eye.
- Executive summary:
A study with the test item according to OECD Guideline 405 was performed to investigate the irritation potential to the rabbit eye.
The test item caused slight reactions of conjunctivae and corneae of the animals. Additionally, eye discharge was observed in the animals one hour after treatment until 72 h. 7 days after treatment all signs of irritation were fully reversible.
Testing of barbituric acid for primary eye irritation in the rabbit showed that the substance has not to be regarde as irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
not classified
Neither skin nor eye irritation studies in vivo indicated an irritating potential.
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