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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:
06 Mar 1992 - 23 Dec 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2.32 ± 0.129 kg
- Housing: singly in wire mesh cages
- Diet (e.g. ad libitum): Altromin K, Type 2123, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Quarantine: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 /h
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 1992-08-04 To: 1992-08-31

Test system

Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Rinsing after 24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

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
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
3
Reversibility:
fully reversible within: Day 10
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
see table below

Any other information on results incl. tables

Rabbit # Time [h] cornea iris conjunctivae  
        redness chemosis
1 24 0 0 2 0
  48 0 0 2 0
  72 0 0 2 0
  average 0.0 0.0 2.0 0.0
2 24 0 0 3 0
  48 0 0 1 0
  72 0 0 2 0
  average 0.0 0.0 2.0 0.0
3 24 0 0 2 0
  48 0 0 1 0
  72 0 0 2 0
  average 0.0 0.0 1.7 0.0
4 24 0 0 3 0
  48 0 0 1 0
  72 0 0 0 0
  average 0.0 0.0 1.3 0.0
5 24 0 0 1 0
  48 0 0 1 0
  72 0 0 1 0
  average 0.0 0.0 1.0 0.0
6 24 0 0 2 0
  48 0 0 1 0
  72 0 0 1 0
  average 0.0 0.0 1.3 0.0
       
  Time [h] cornea iris conjunctivae  
        redness chemosis
average 24 0.00 0.00 2.17 0.00
score 48 0.00 0.00 1.17 0.00
  72 0.00 0.00 1.33 0.00
  24+48+72 0.00 0.00 1.56 0.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
DMPT is mildly irritating to eyes, but does not meet the CLP criteria for classification as an eye irritant.