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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study and GLP

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)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Palmitic acid
EC Number:
200-312-9
EC Name:
Palmitic acid
Cas Number:
57-10-3
IUPAC Name:
palmitic acid
Constituent 2
Reference substance name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
IUPAC Name:
[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Mean weight: 2640.0g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 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 left eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g


Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The test animals were observed 1, 6, 24, 48 and 72 hours after exposure.
Number of animals or in vitro replicates:
4
Details on study design:
24 hours before applying the eye of the rabbits were checked for their health. The untreated eyes of the rabbits were studied using a 0.5% aqueous sodium fluorescein solution to verify whether the cornea was intact.
This examination was repeated 24 hours after the administration of the test substance, after the membranes had already been examined macroscopically on inflammatory symptoms and evaluated on the basis of the Draize test.
0.1 g of the substance were administered in the conjunctival sac of the right eye and the eyelids brought together briefly. The left eye remained untreated and served as a control. The mucous membranes of the eyes remained in constant contact with the test substance.
The observation time of the animals was three days afer exposure, but the reactions were recorded 1, 6, 24, 48 and 72 hours after the application.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
Reactions of the cornea were not observed.
Reactions of the iris were not observed.
The conjunctival reactions were slight. Within 48 hours, no animals showed symptoms.
That no corneal reactions had occurred was confirmed using the fluorescein method.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance Edenor C16 - 92/94 (FS 008) shoes no eye irritation potential.
Executive summary:

The test substance Edenor C16 - 92/94 (FS 008) was tested for primary eye irritation on rabbits by a single application of 0.1 g of the undiluted test product and permanent contact. The exposure duration was 72 hours. The animals were observed 1, 6, 24, 48 and 72 hours after the application.

The test was performed according the OECD Guideline No 405.

Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours.

The test substance Edenor C16 - 92/94 (FS 008) shoes no eye irritation potential.