Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
02.02.1981-11.02.1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a protocol that is comparable to current guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C9-11 alcohols Cas# 66455-17-2 (Neodol 91) 84% linear monobranched at the 2 position

- Physical state: clear liquid


Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Camm Research Institute, USA
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: Individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 20.9C
- Humidity (%): average 56.3


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
0.5 minute(s)
Observation period (in vivo):
7 days (examination points at 1, 24, 48 and 72 hours and at 7 days)
Number of animals or in vitro replicates:
3M+3F unrinsed; 3M rinsed.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize, 1963 plus Kay & Callandra 1962 (modified)

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
other: nonwashed eyes
Time point:
other: 24 hours
Score:
8.8
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.17
Max. score:
0.67
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Remarks on result:
other: unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.5
Max. score:
0.67
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: unrinsed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.39
Max. score:
1.3
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
AVERAGE SCORE (24+48+72 hour) rinsed
- Cornea: individual scores all 0 (group mean score 0)
- Iris: Individual scores all 0 (group mean score 0)
- Conjunctivae (Redness): individual scores 0.3, 0, 0.3 (group mean score  0.2) -
 Conjunctivae (Chemosis): individual scores 0.3, 0, 0.3 (group mean  score 0.2)
- Overall irritation score: Maximum mean total score 4.7 at 1 hours after  instillation.

All scores were 0 at 7 days both rinsed and unrinsed.
Other effects:

Conjunctival discharge reported in some rabbits up to 48  hours post instillation (unrinsed) and 1 hour after instillation (rinsed).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Neodol 91 is not an eye irritant by either EU or GHS criteria.