Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; scoring system not according to OECD405). Study sufficient for evaluation of this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 50 µl; no washing after 24 h
Principles of method if other than guideline:
White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline-treated adjacent eye served as a control. The animals were observed several times on the treatment day and up to 7 or 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
stearic acid chloride
IUPAC Name:
stearic acid chloride
Details on test material:
- Name of test material (as cited in study report): Stearinsäurechlorid
- Physical state: liquid
- Analytical purity: 98 %
- pH: acidic
- melting point: 7,3

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Observation period (in vivo):
study terminated afte 48 h
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM
see table below

TOOL USED TO ASSESS SCORE
fluorescein at the end of the study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
slight erythema (1), and a minimal/questionable edema was observed 3 h after application. The effects were fully reversible with in 1 day. The study was terminated after negative fluorescein staining 48 h after application
Other effects:
Traces of blood were visible 3 h after application in both animals. The finding may be due to attemps of the animals to clean their eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Because of the full reversibility of the minimal effects observed within the first 3 h after application the substance is classified as non- irritating.
Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions. White Vienna rabbits were used. 50µl of the test substance were applied to the conjunctival sac of one eye of 2 animals. The eyes were not washed out after 24 hours.

No effects were observed 24 h after application

Conclusion

Because no effects were observed 24 h after application the substance is classified as non- irritating.