Registration Dossier
Registration Dossier
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EC number: 223-834-9 | CAS number: 4091-39-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-chlorobutan-2-one
- EC Number:
- 223-834-9
- EC Name:
- 3-chlorobutan-2-one
- Cas Number:
- 4091-39-8
- Molecular formula:
- C4H7ClO
- IUPAC Name:
- 3-chlorobutan-2-one
- Reference substance name:
- 3-Chloro-2-butanone
- IUPAC Name:
- 3-Chloro-2-butanone
- Test material form:
- other: colourless liquid
- Details on test material:
- Purity:> 98% (GC)
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- 3 male rabbits
Initial body weight: 2.0 - 2.2 kg
Approx. 4 months of age
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Single instillation into the conjunctival sac, 0.1 mL of the test substance was administered per eye and tested in three
animals.
The test substance was placed in the conjunctival sac of the right eye of each animal
after gently pulling the lower lid away from the eyeball. The lids were then
gently held together for about one second in order to prevent loss of the material.
The left eye, which remained untreated, served as a control.
The eyes of the animals were not rinsed. - Duration of treatment / exposure:
- Theeyeswereexaminedophi:halmoscopically wifha slifIamp prior faThead:
ministration and 1, 24, 48 and 72 hours after the administration. The eye reactions
were observed and registered.
24 hours after administration the eyes were treated additionally with fluorescein4
and examined. - Observation period (in vivo):
- Theeyeswereexaminedophi:halmoscopically wifha slifIamp prior faThead:
ministration and 1, 24, 48 and 72 hours after the administration. The eye reactions
were observed and registered.
24 hours after administration the eyes were treated additionally with fluorescein4
and examined. - Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- 0.1 mL of the test substance was administered per eye and tested in three
animals.
The test substance was placed in the conjunctival sac of the right eye of each animal
after gently pulling the lower lid away from the eyeball. The lids were then
gently held together for about one second in order to prevent loss of the material.
The left eye, which remained untreated, served as a control.
The eyes of the animals were not rinsed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.33
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.33
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.67
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.67
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.67
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.33
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.67
- Irritant / corrosive response data:
- Under the present test conditions a single instillation of 0.1 mL 3-Chlorbutanon-2
per anima~intothe conjunctival sac of the right eve of-three rabbits-caused the
following effects:
Corneal opacity was observed
- in animal no. 1: 1 hour (grade 1) and 24 hours to 7 days (grade 2) and 8 days
(grade 1) after instillation,
- in animal no. 2: 1 hour (grade 1), 24 hours (grade 2) and 48 hours to 7 days
(grade 1) after instillation,
- in animal no. 3: 1 hour (grade 1), 24 hours (grade 2) and 48 hours to 5 days
(grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining
in animal no. 1 (3/4 of the surface) and in animal nos. 2 and 3 (1/2 of the
surface). The fluorescein test performed 7 days after instillation revealed corneal
staining in animal no. 1 (112 of the surface) and in animal no. 2 (1/4 of the
surface).
An irritation of the iris was noted in animal nos. one and two 24 hours to 4 days
after instillation, in animal no. 1 until 5 days after instillation.
Conjunctival redness (grade 1) was observed in all animals 1 hour to 5 days after
instillation, in animal nos. 1 and 3 until 6 days after instillation.
Conjunctival chemosis was observed
- in animal no. 1: 1 and 24 hours (grade 3), 48 hours (grade 2) and 72 hours to 5
days (grade 1) after instillation.
- in animal no. 2: 1 hour (grade 1), 24 hours (grade 2) and 48 hours (grade 1)
after instillation and
- in animal no. 3: 1 and 24 hours (grade 3) and 48 hours to 5 days (grade 1)
after instillation.
In addition, whitish deposits (probably pus) in the conjunctival sac were observed
in animal nos. one and three 48 hours to 4 days after instillation, in animal no. 1
until 5 days after instillation. Hair loss around the eye lid was noted in animal
no. three 24 hours after instillation. - Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- 3-Chloro-2-butanone was found to be irritating to the eye in an OECD 405 guideline study.
- Executive summary:
Under the present test conditions a single instillation of 0.1 mL 3-Chlorbutanon-2
per animal into the conjunctival sac of the right eye of three rabbits caused the
following effects:
Corneal opacity was observed
- in animal no. 1: 1 hour (grade 1) and 24 hours to 7 days (grade 2) and 8 days
(grade 1) after instillation,
- in animal no. 2: 1 hour (grade 1), 24 hours (grade 2) and 48 hours to 7 days
(grade 1) after instillation,
- in animal no. 3: 1 hour (grade 1), 24 hours (grade 2) and 48 hours to 5 days
(grade 1) after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining
in animal no. 1 (3/4 of the surface) and in animal nos. 2 and 3 (1/2 of the
surface). The fluorescein test performed 7 days after instillation revealed corneal
staining in animal no. 1 (1/2 of the surface) and in animal no. 2 (1/4 of the
surface).
An irritation of the iris was noted in animal nos. one and two 24 hours to 4 days
after instillation, in animal no. 1 until 5 days after instillation.
Conjunctival redness (grade 1) was observed in all animals 1 hour to 5 days after
instillation, in animal nos. 1 and 3 until 6 days after instillation.
Conjunctival chemosis was observed
- in animal no. 1: 1 and 24 hours (grade 3), 48 hours (grade 2) and 72 hours to 5
days (grade 1) after instillation.
- in animal no. 2: 1 hour (grade 1L 24 hours (grade 2) and 48 hours (grade 1)
after instillation and
- in animal no. 3: 1 and 24 hours (grade 3) and 48 hours to 5 days (grade 1)
after instillation.
In addition, whitish deposits (probably pus) in the conjunctival sac were observed
in animal nos. one and three 48 hours to 4 days after instillation, in animal no. 1
until 5 days after instillation. Hair loss around the eye lid was noted in animal
no. three 24 hours after instillation.
There were no systemic intolerance reactions.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments
on the approximation of the laws, regulations and administrative provision
relating to the classification, packaging and labelling of dangerous substances and
the results obtained under the present test conditions
3-Chlorbutanon-2 was irritating to eyes, labelling requirement: R36.
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