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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:
From July 11 to 21, 2005
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:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on non-ocular local and systemic adverse effects
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Clear colourless liquid
Details on test material:
- Name of test material (as cited in study report): TMPTMA
- Physical state: Clear colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) (BCM IPS Limited, London, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not applicable

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Eye examinations were performed using light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
- Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation; irritation completely resolved within 72 hours
- See table 1 and 2 for further details
Other effects:
No data

Any other information on results incl. tables

Table 1: Individual eye irritation scores

Animal

Time after dosing (hours)

Cornea

Iris

Conjunctivae

Opacity

Area

Redness

Chemosis

Discharge

126 Male

1

0

0

0

1

0

1

24

0

0

0

1

0

0

48

0

0

0

1

0

0

72

0

0

0

0

0

0

30 Male

1

0

0

0

1

1

1

24

0

0

0

1

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

31 Male

1

0

0

0

1

1

1

24

0

0

0

1

0

0

48

0

0

0

0

0

0

72

0

0

0

0

0

0

Table 2: Mean (24, 48 and 72 hours) value eye irritation scores

Animal

Corneal opacity

Iris

Conjunctivae

Redness

Chemosis

126 Male

0

0

0.7

0

30 Male

0

0

0.3

0

31 Male

0

0

0.3

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not eye irritating
Conclusions:
Under the test conditions, TMPTMA is not classified as irritating to the eye according to the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted TMPTMA in their right eye (under local anaesthesia) while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of Draize (1977).

 

Minimal conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 hour observation. The irritation completely resolved within 72 hours. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 0.3, 0.3 for conjunctivae score and 0, 0, 0 for chemosis score.

 

Under the test conditions, TMPTMA is not classified as irritating to the eye according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).