Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 November 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D-1411
- Physical state: a clear yellow coloured liquid
- Storage condition of test material: room temperature, in a glass screw-top bottle

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, Sandbach, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 3.05 kg
- Housing: 1/suspended metal cage
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1987-11-09 To: 1987-11-09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required - untreated eye is the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat
Duration of treatment / exposure:
30 min (test animal sacrificed for humane reasons after 30 min)
Observation period (in vivo):
30 mins
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not irrigated

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: light from standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 30 min
Score:
3
Max. score:
4
Reversibility:
other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 30 min
Score:
1
Max. score:
2
Reversibility:
other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 30 min
Score:
3
Max. score:
3
Reversibility:
other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 30 min
Score:
4
Max. score:
4
Reversibility:
other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
animal was sacrificed in humanity after 30 min of observation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
animal was sacrificed in humanity after 30 min of observation
Irritant / corrosive response data:
Total score (one rabbit @ 30 mins): 85/110. Opalescent cornal opacity, iridial inflamation, severe conjunctival irriation. See table 1.
Other effects:
Conjunctival blood stained discharge and haemorrhage. Haemorrhage from nicating membranes.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for a single animal (study terminated at 30 mins)

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Discharge

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 3

30 min

3

1

3

4

3

Area effected

 4

-

-

-

-

Total score 85/110

60/80

5/10

20/20 

Reversibility

Not possible to assess; unlikely to be reversible

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are met, Category 1 (irreversible effects on the eye) classification required according to Regulations (EC) No 1272/2008
Conclusions:
A reliable study, conducted according to OECD 405 and GLP, reported corneal opacity, iridial inflamation and severe conjunctival irritation and a Draize score of 85 out of 110, in a single rabbit. The score was judged in the report to indicate that the test material was a very severe to extremely severe irritant to the eyes of rabbits, and would be considered to cause irreversible eye effects according to EU criteria.