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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it closely followed OECD Guideline 405 and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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): Emery 3004
- Substance type: Poly Alpha Olefin (1-decene trimer and tetramer, hydrogenated)
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: #8BU28
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other: Clear liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Individual in wire mesh cages
- Diet (e.g. ad libitum): Purina Laboratory Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light


IN-LIFE DATES: From: 1988-03-23 To: 1988-03-31

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitres
- Concentration (if solution): Not reported

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: Method of Draize (1959)


TOOL USED TO ASSESS SCORE: Gross ocular examinations only

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
animal: 1 and 6
Time point:
other: 72 hours
Score:
> 0 - < 2
Max. score:
2
Reversibility:
not specified
Irritant / corrosive response data:
Two animals showed signs of conjunctival erythema; for one, signs cleared up by 72 hours, while for the other, signs appeared at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the reported results, Emery 3004 was not classified as an irritant to rabbit eyes.
Executive summary:

In a primary eye irritation study, 0.5 mL of Emery 3004 (Undiluted) was instilled into the right eye of 6 naïve female New Zealand White rabbits for 24 hours. Eyes of the test animals were not rinsed post exposure. Animals then were observed for 72 hours and irritation was scored by the method of Draize (1959).

 

Two animals showed signs of conjunctival erythema; for one, signs cleared up by 72 hours, while for the other, signs appeared at 72 hours. Based on the reported results, Emery 3004 is not an eye irritant.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD Guideline 405 and was GLP compliant. 

 

This study will influence the DNEL.