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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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: without restrictions valid
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
TEPIC-S (lot 610806, purified) TGIC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
One Female New Zealand White rabbit, 12 - 16 weeks old, 2.9 kg bw,
5 days acclimatization period, single caging, free acces to water and diet,
room temperature: 18-20°C, relative humidity: 58%, 15 air changes/hour, 12 hour day-night cycle.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
few minutes , then washing
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
one (1)
Details on study design:
The right eye was treated, the left eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animals killed for humane reasons at 4hrs
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animals killed for humane reasons at 4hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Animals killed for humane reasons at 4hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
strong irritant to eyes

Any other information on results incl. tables

Severe ocular reactions with obvious signs of pain were seen in the single treated animal approximately 4 hours after treatment. Conjunctival reactions , identiffied by beefy redness, with haemorrhage of the capillaries of the conjunctival and nictitating membranes, severe chemosis and an extensive discharge were noted. The severity of the chemosis precluded examination of the cornea and iris at this stage.

For Humane reasons, the animal was killed and the cornea and iris were examined immediately after death. Diffuse corneal opacity and iridial inflammation were noted at this time.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
TGIC was highly irritant in the rabbit eye.
Executive summary:

TGIC was highly irritant in the rabbit eye.