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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-12
EC Number:
271-642-9
EC Name:
Alcohols, C6-12
Cas Number:
68603-15-6
IUPAC Name:
octan-1-ol
Details on test material:
- Name of test material (as cited in study report): Tradename Linevol 79, C6-12 alcohols Type C

- Physical state: clear, colourless liquid

- Storage condition of test material: cool conditions (not exceeding 15C), protected from light in the original container

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield SPF Rabbits, Hampshire, UK
- Age at study initiation: 5 months
- Weight at study initiation: 2.7 - 2.97 kg
- Housing: individually housed in suspended stainless steel cages mounted in mobile batteries.
- Diet: standard pelleted rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, but unspecified


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23
- Humidity (%): 40-70
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18.10.1995 To: 11.12.1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single instillation, unwashed
Observation period (in vivo):
The behaviour of each rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response. Ocular reaction to treatrment were assessed 1, 24, 48 and 72 hours after treatment. Additional observations of persistent ocular lesions or irritation responses were made on days 8, 15, 22 and 29 (last day of observation period).
Number of animals or in vitro replicates:
3F
Details on study design:
SCORING SYSTEM: According to OECD guideline

TOOL USED TO ASSESS SCORE: ophthalmoscope or pencil beam torch. From 24  hours as required one drop fluorescein used to assess corneal injury.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 29 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 29 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 29 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.1
Max. score:
1.3
Reversibility:
fully reversible within: 29 days
Irritant / corrosive response data:
AVERAGE SCORE (24+48+72 hours)
- Cornea: individual scores all 2 (group mean score 2)
- Iris: individual scores all 1 (group mean score 1)
- Conjuntivae (Redness): individual scores all 2 (group mean scores 2)
- Conjunctivae (Chemosis): individual scores 1.3, 1.3, 0.7 (group mean  score 1.1)

REVERSIBILITY: After 7 days conjunctivial injection was apparent in all  animals (grade 1 some vessels definitely injected) persisting in two  animals until day 22. By day 29 all eyes were overtly normal.
Other effects:
Crimson-red conjunctival appearance, very slight/slight chemosis and discharge, iritis and slight corneal opacity  covering up to the entire corneal surface were observed during the first  72 hours post instillation. Corneal stippling observed in one animal at  48 hours. Very slight initial pain response.

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Linevol 79 is an eye irritant according to EU criteria based on a mean 24+48+72 hour score for iritis of 1 in all test animals. Based on scores for conjunctivitis and corneal opacity of 2 and iritis of 1 and eventual reversibility of the response by 29 days (effects at 22 days were minimal) Linevol 79 is considered a category 2 eye irritant under CLP.

Classification: irritating

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