Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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:
Acid chlorides, coco
EC Number:
269-133-1
EC Name:
Acid chlorides, coco
Cas Number:
68187-89-3
Molecular formula:
variable
IUPAC Name:
Acid chlorides, coco
Constituent 2
Reference substance name:
Fatty acids, coco, chlorinated
EC Number:
307-160-3
EC Name:
Fatty acids, coco, chlorinated
Cas Number:
97553-06-5
IUPAC Name:
97553-06-5
Constituent 3
Reference substance name:
Cocoyl chloride
IUPAC Name:
Cocoyl chloride
Constituent 4
Reference substance name:
96/239
IUPAC Name:
96/239
Details on test material:
- Name of test material (as cited in study report): Kokosfettsaeurechlorid)
- Batch No.: Vers. 148/U
- Physical state: clear liquid, yellowish
- Analytical purity: 99.5 % (by GC)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: confirmed by the analytical report 98L00389 as stated in the 1st amendment
- Storage condition of test material: at room temperature under exclusion of moisture and oxygen (nitrogen atmosphere)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach (Germany)
- Age at study initiation: young adult
- Weight at study initiation: 3.19 - 3.99 kg
- Housing: single
- Diet: Kliba Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, CH) ca. 130 g per day
- Water: tap water ca. 250 g per day
- Acclimatization: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3 (two males, one female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: tap water

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Other effects:
Discharge (Score 1 or 2) was observed within the first 24 h; see table for details

Any other information on results incl. tables

Exposition:

24 h

 

 

 

 

 

Animal

Reading

Opacity

Iritis

Redness

Chemosis

Symptoms

1

1 h

0

0

2

1

discharge score 2

2

1 h

0

0

2

0

discharge score 1

3

1 h

0

0

2

1

discharge score 1

1

24 h

0

0

2

1

 

2

24 h

0

0

2

0

discharge score 1

3

24 h

0

0

1

0

 

1

48 h

0

0

2

1

 

2

48 h

0

0

1

0

 

3

48 h

0

0

1

0

 

1

72 h

0

0

2

1

loss of hair in the margines of eyelids

2

72 h

0

0

0

0

 

3

72 h

0

0

1

1

 

1

8 d

0

0

0

0

loss of hair in the margines of eyelids

2

8 d

0

0

0

0

 

3

8 d

0

0

0

0

 

mean

24 - 72 h

0.00

0.00

1.33

0.44

 

Applicant's summary and conclusion

Executive summary:

The study was performed comparable to OECD guideline 405 and GLP requirements and is relable without restrictions. 0.1 mL of the unchanged test substance was instilled to the eyes of three rabbits and washed out after 24 h. Effects on corneal opacity and the iris were not observed, the scores for conjuctivae redness and chemosis were 1.3 and 0.4, respectively (mean of the 24, 48 and 72 h readings).

Conclusion

Following the conditions of the test, cocoyl chloride has not to be considered as irritating to the eyes.