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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
Study period:
26 Feb - 04 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance CAS 57-10-3. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Edenor C16 - 92/94 (FS 008)
- Physical state / appearance: white powder
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen Chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HM / Fa. Thomae, Biberach, Germany
- Weight at study initiation: ca. 2640 g
- Housing: individually (Fa. Heinkel, Kuchen, Germany)
- Diet (ad libitum): Altromin diet 2023, Altromin GmbH, Lage, Germany
- Water (ad libitum): community tap water; ad libitum
- Acclimation period: at least 7 days


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eyes of the same animals were used for control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
permanent, without washing-off
Observation period (in vivo):
3 days (since only minor scores were observed that fully returned to normal within 3 days the experiment was cancelled due to animal welfare reasons; therefore the reduced observation period does not represent a deviation to the OECD guideline)
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
4 animals
Time point:
other: mean 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
4 animals
Time point:
other: mean 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
4 animals
Time point:
other: mean 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within:
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
4 animals
Time point:
other: mean 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
other: exudation
Basis:
mean
Remarks:
4 animals
Time point:
other: mean 24 - 48 - 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects

Any other information on results incl. tables

Tab.1: Conjunctival reactions after application of 0.1 g Edenor C16 - 92/94 (undiluted, permanent, 4 male rabbits)

Time point after application

Redness

Chemosis

Exudation

Individual data

Average

Individual data

Average

Individual data

Average

60 min

1 / 1 / 1 / 1

1.00

0 / 1 / 1 /1

0.75

0 / 0 / 0 / 1

0.25

6 h

1 / 2/ 1 / 1

1.25

0 / 0 / 0 / 0

0

2 / 0 / 0 / 1

0.75

24 h

1 / 1 / 1 / 1

1.00

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

48 h

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

72 h

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

Animal No. (from left to right) 790, 796, 798, 799

Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours. Palmitic acid is not irritating to eyes / mucosa under the test conditions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU