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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:
supporting study
Study period:
26 Feb - 04 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C8-24
EC Number:
275-164-1
EC Name:
Fatty acids, C8-24
Cas Number:
71076-48-7
Molecular formula:
C8H16O2 - C24H48O2
IUPAC Name:
71076-48-7
Details on test material:
- Name of test material (as cited in study report): Polyresidal F (FS 017) (destillation residue of unsaturated fatty acids)
- Physical state: black, waxy solid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Himalayan Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult animals
- Weight at study initiation: 2517.5 g (mean)
- Housing: individually in a rabbit battery (Fa. Heinkel, Kuchen, Germany)
- Diet: Altromin diet 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g


Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
3 days
reading time points: 1, 6, 24, 48 and 72 h
Number of animals or in vitro replicates:
4 males
Details on study design:
PREPARATION OF THE TEST SUBSTANCE
The test item was prewarmed to enable the application of a fluidized test substance in the conjunctival sac of the right eye.

REMOVAL OF TEST SUBSTANCE
The test item was in contact with the eye permanently. No removal of the test item occured.

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
other: mean out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No reactions on iris or cornea were observed which was confirmed after fluorescein treatments.

Slight effects (grade 1) on the conjunctiva (redness) were observed in 3 animals which were fully reversible within 24 - 48 h in all animals (Table 2).
Two animals showed signs of exsudation (score 1 and 2, max. score: 4) 1 h after application which was fully reversible within 6 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified

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