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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 11 February 2008 and 21 February 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 21/8/2007. Date of signature: 15/10/2007

Test material

Constituent 1
Reference substance name:
-
EC Number:
482-220-0
EC Name:
-
Cas Number:
848301-69-9
IUPAC Name:
1-(2-methylpentyl)-3-(6-methylundecyl)cyclopentane; 1-(3,7-dimethyldecyl)-3-(2-methylbutyl)cyclohexane; 1-(3-methyldecyl)-3-(2-methylpentyl)cyclohexane; 4,8,11-trimethylpentadecane; 6,9-dimethylhexadecane; 6-methylheptadecane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continous light and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single application of test material (72 hours).
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Immediately after administration of the test material, an assessment of the initial pain reaction was made.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical Draize Scale for Scoring Ocular Irritation.

Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
: animal 67182
Time point:
other: 24, 48 and 2 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
: animal 67215
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
: animal 67216
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
: animal 67182
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
: animal 67215
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
: animal 67216
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
: animal 67182
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
: animal 67215
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
: animal 67216
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
: animal 67182
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
: animal 67215
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
: animal 67216
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
No corneal or iridial effects were noted.

Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation.

One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.
Other effects:
Initial pain reaction: Slight initial pain in all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:

Rabbit Number: 67182
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.0
Chemosis: 0.0

Rabbit number: 67215
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0

Rabbit number: 67216
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0

Based on these results the substance is not classified as an eye irritant.
Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material ‘Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear’ to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)

• Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004173/EC

Result.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.

The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:

Rabbit Number: 67182

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.0

Chemosis: 0.0

Rabbit number: 67215

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

Rabbit number: 67216

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

The test material did not meet the criteria for classification as irritant according to Regulation (EC) No 1272/2008.