Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
November 1981
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
eye rinsed after 30sec instead of 1 hour and not all the required data are given in the test report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The eyes of the tested animals were rinsed after 30 seconds instead of 1 hour.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Each rabbit was sexed, weighted and ear tagged with a unique animal numer (weight range: 1.95 kg to 2.55kg). The rabbts were quarantined and acclimated to laboratory conditions for 12 days prior to initiation of the study. The rabbits were individually housed in stain-less steel wire-bottomed cages suspended above the droppings. Animals were observed twice daily during the quarantine period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100mg applied to the right eye - 6 not rinsed and 3 rinsed after 30 seconds
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 animals (4 males and 5 females)
Details on study design:
Grading for irrittation and injury were made at 24, 48 and 72 hours and at 4 and 7 days, using the standard scoring system of Draize. Fluoroscein examinations were used to facilitate evaluation of potential corneal damage.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 h - 4d - 7d
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 72h for rinsed animals - 7 days for not rinsed animals
Irritant / corrosive response data:
The primary irritation index was calculated to be 4.0 for the not rinsed test animals and 1.33 for the rinsed test animals.
Other effects:
no signs of systemic toxicity and no deaths occurred

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritant for eyes.
Executive summary:

The primary eye irritation index was calculated to be 1.33 for the rinsed test animals and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for eyes.