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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996/04/09-1996/04/13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an OECD test guideline and in compliance with GLP. The study is a read across from hexadecanol (CAS 36653-82-4).

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KALCHOL 6098

- Physical state: white granular solid

- Lot/batch No.: 2439

- Storage condition of test material: room temperature in the dark

- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.

Test animals / tissue source

Species:
other: New Zealand White rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK

- Age at study initiation: 12-16 weeks

- Weight at study initiation: 2.69-3.01kg

- Housing: The animals were individually housed in suspended metal cages.

- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)

- Water: tap water (ad libitum)

- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-19C

- Humidity (%): 56-61%

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of each rabbit was used as a control.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): A volume of 0.1ml of the test material which was found to weight approximately78mg was applied to the eye.


VEHICLE

-No vehicle.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1h, 24h, 48h, 72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): No washing reported.


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the toxicity of Household Substances,National Academy of Sciences, Washington DC p. 48 to 49. Classification According to a Modified Version of the Kay and Calandra System

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Iridial inflammation
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #1
Time point:
other: mean 24h,48h,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Iridial infalmmation
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
other: No initial effect.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Iridial inflammation.
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #3
Time point:
other: mean 24, 48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritant / corrosive response data:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letter E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:

Score for the conjunctivae - (A+B+C)x2
Score for iris - Dx5
Score for cornea - (ExF)x5

Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C, J.Soc.Cosmet Chem., 1962 13 281-289 wasused to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. If any rabbit shows irreversible oculardamage the test material will be classified as corrosive to the eye.

Overall irritation score: Maximum group mean score 15.3 at 1 hour post instillation. Classified as a mild irritant according to a modified Kay and 
Calandra system.
Other effects:
DESCRIPTION OF LESIONS: Dulling of the cornea noted in 2 animals 1 hour after instillation, diffuse corneal opacity noted in 1 rabbit at 24 hours 
post instillation. Iridial inflammation noted in 2 animals at 1 hour post instillation only. Moderate conjunctival irritation noted in all eyes at 1 hour 
which reduced to minimal conjunctival irritation at 24 hours.
REVERSIBILITY: All eyes were normal at 48 and 72 hours post instillation.
OTHER EFFECTS: Residual test material noted around the treated eyes at 1 hour post instillation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol 6098 is not an eye irritant according to EU or GHS criteria. The result is a read across from hexadecanol (CAS 36653-82-4).