Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP but in accordance with the guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline FEDERAL REGISTER vol. 38 n. 187, s.27019/1973
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Parachlorbenzotrifluorid
- Physical state: colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1,5 -2,0 kg
- Housing: individually caged
- Diet: ERKA 8300 ad libitum
- Water: ad libitum


IN-LIFE DATES: From: 3 February To: 7 February

Test system

Vehicle:
other: sesame oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL undiluted
Duration of treatment / exposure:
24 hs
Observation period (in vivo):
Up to 72 hs
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological solution
- Time after start of exposure: 24 hs

SCORING SYSTEM: According to FDA Classification , 1959 s.51, reported in the Table below.

TOOL USED TO ASSESS SCORE: fluorescein in dilution 0.01 %, instilled after 48 and 72 hs.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item results not irritant to the rabbit eye.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The test item results not irritating to the rabbit eye.
Executive summary:

The test item was instilled into the right eye of 6 rabbits, while the left eye served as control. 0.1 mL of undiluted product was instilled in the eye and washed after 72 hs. The observation period was up to 72 hs. Fluorescein was instilled after 48 hours and 72 hours to assess the scores. The irritation index was calculated based on effects on cornea, iris and conjunctiva after 1, 7, 24, 48 and 72 hours. The maximum score was 2 and it was observed after 7 hours. The effect was fully reversible after 24 hours. Therefore, the product is classified as not irritant to eyes.