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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 March 2012 to 26 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted to current guidelines and GLP without significant deviation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4,4-biphenol
- Physical state:powder
- Analytical purity:99.9%
- Purity test date: 9 September 2011
- Lot/batch No.: 071111370
- Expiration date of the lot/batch: 11 July 2016
- Storage condition of test material: Ambient room temperature
- Other: description off white to white cream coloured powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Harlan Italy s.r.l., San Pietro al Natisone, Italy
- Age at study initiation: 9-11 weeks old
- Weight at study initiation: 3.36 to 4.25 Kg
- Housing: Noryl cages with suspended perforated floors
- Diet (e.g. ad libitum): ad libitum Stanrab (P) SQC from Special Diet Services
- Water (e.g. ad libitum): ad libitum via cage bottles
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19+/-2
- Humidity (%): 55+/-15
- Air changes (per hr):15-20
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 12 March 2012 To: 15 March 2012

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye
- Concentration (if solution): not applicable
Duration of treatment / exposure:
Single application on Day 1. The eyes were not rinsed to remove the test material from the eye after a fixed period of time.
Observation period (in vivo):
Rabbits were observed for 72 hours after instillation.
Number of animals or in vitro replicates:
Three. The sentinel was dosed first followed by the remaining two rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: Draize system, according to test guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no corneal reactions observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No iridial changes recorded
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: very slight erythema/conjnuctival redness recorded after one hour in one rabbit. Reactions had resolved by the 24 h assessment
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no reeaction observed
Irritant / corrosive response data:
No significant ocular irritation was observed in any of the three treated rabbits. Mean scores for all parameters measured over the 24-72 h post instillation period were 0.0. No classification is required for ocular irritancy, No signal word or Hazard Statement required in accordance with Regulation 1272/2008
Other effects:
None

Any other information on results incl. tables

No further information, no significant irritation effects observed in the study

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not an eye irritant
Executive summary:

Three rabbits were treated by instillation of 100 mg of undiluted 4,4-biphenol. The untreated eye acted as a concurrent control. Observations were recorded at 1, 24, 4 and 72 hours after instillation. Only one rabbit showed any changes with very slight conjunctival redness apparent at the first assessment point but resolved within 24 hours of dosing. No reactions were observed in the other two rabbits. The results of the in vivo test confirm the earlier in vitro assessment of severe irritation or corrosion, supporting the conclusion that no classification is required for 4,4 -biphenol and no signal word or Hazard statement is needed in accordance with the requirements of Regulation 1272/2008.