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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Reagens-S-CFZ (CHPT), 65% aqueous solution

65% aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Herts, UK
- Age at study initiation: 20-24 wk
- Weight at study initiation: 2.2-3.1 kg
- Housing: 1/metal cage with perforated base
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye serves as control
Amount / concentration applied:
Concentration: 65%
Amount applied: 0.1 mL
Duration of treatment / exposure:
examination after 1 h
Observation period (in vivo):
Examined at 1 h and 1, 2, 3, 4 and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand torch

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
All symptoms were fully reversible within 96 hours.

Any other information on results incl. tables

Cornea: 0, 24, 72 h, 48 h: 1 animal: 1, 2 animals: 0,  Iris:
0 (3 animals, 24, 48, 72 h), 
Conjunctiva redness: 24 h: 2 (2 animals), 1 (1 animal)
                     48 h: 2 (3 animals)
                     72 h: 1 (3 animals)
After 4 and 7 days: 0 (3 animals).
Conjunctiva chemosis: 24 h: 2 (1 animal), 1 (2 animals)
                      48 h: 1 (3 animals)
                      72 h: 1 (2 animals), 0 (1 animal)
After 4 and 7 days: 0 (3 animals).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
A reliable study, conducted according to OECD 405 and GLP, reported transient irritation, particularly of the conjunctiva, from a 65% aqueous solution of CHPTAC, that had resolved by 96 h. The scores would not meet EU criteria for classification.
Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of CHPTAC (65%) was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival reactions were observed, which were fully reversible within 96 hours. In this study, the test item is not an eye irritant.