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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:
22 December 2009 - 01 January 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Tall-oil pitch
EC Number:
232-414-4
EC Name:
Tall-oil pitch
Cas Number:
8016-81-7
Molecular formula:
UVCB substance molecular formula unknown
IUPAC Name:
Tall-oil pitch
Details on test material:
- Name of test material (as cited in study report): CAS No 8016-81-7 Tall oil pitch

- Physical state: black viscous liquid

- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Harlan Laboratories U.K. Ltd., Hillcrest, Belton, Loughborough, UK.

- Age at study initiation: 12 - 20 weeks

- Weight at study initiation: 2.38-2.73kg

- Housing: the animals were individually housed in suspended cages

- Diet: 2030 Teklad Global Rabbit diet, ad libitum

- Water: ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-23

- Humidity (%): 30-70

- Air changes (per hr): minimum 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
Single instillation, unwashed.
Observation period (in vivo):
Assessment for ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: Draize 1977


TOOL USED TO ASSESS SCORE: opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h mean
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h mean
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 hour observation. Both treated eyes appeared normal at the 48 hour observation.
Other effects:
Black/brown coloured staining of the fur was noted around both treated eyes throughout the study. Both animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tall Oil Pitch was not irritant to rabbit eyes according to EU criteria in a test conducted according to the appropriate OECD test guideline and in compliance with GLP.

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