Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1994-01-24 until 1994-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
other: amendment to study report
Title:
Unnamed
Year:
1995
Report date:
1995
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl methacrylate
EC Number:
209-548-7
EC Name:
tert-butyl methacrylate
Cas Number:
585-07-9
Molecular formula:
C8H14O2
IUPAC Name:
tert-butyl 2-methylprop-2-enoate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (supplier): BASF
- LOT number of test material: LAB.-J.-NO. 387
- Purity: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator, exclusion of light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: The stability of the test substance over the study period was proved by reanalysis. The result was reported in the form of an amendment (12 January 1995). According to the analytical determination, dated December 07, the test substance was stable over the study period. The sample appeared to be homogeneous.

FORM AS APPLIED IN THE TEST
- The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of the test animals.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult (not further specified)
- Weight at study initiation: 3.67 - 4.37 kg
- Housing: single housing
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, Switzerland, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): not specified
- Photoperiod:12 H/12 H (6.00 a.m.- 6.00 p.m./6.00 p.m. - 6.00 a.m.)

IN-LIFE DATES: not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each tested animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
unwashed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The substance was not washed out.

SCORING SYSTEM: Draize scoring (for more details please refer to "Any other information on materials and methods incl. tables")

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
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
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
mean
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
Remarks:
mean
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
Remarks:
mean
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
Remarks:
mean
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
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The numerical scores awarded to the eye reactions elicited by the test substance are given in Table 1.

Any other information on results incl. tables

Table 1: TABULATION OF IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME AS WELL AS CALCULATION OF THE MEANS.






























































































































































Animal Reading OpacityIritisRednessChemosisSymptoms
11 h0021discharge score 3; small retractions of the eye lids
21 h0000 
31 h0010discharge score 1
124 h0020small retractions of the eye lids
224 h0000 
324 h0021discharge score 1
148 h0020small retractions of the eye lids
248 h0000 
348 h0020discharge score 1
172 h0020small retractions of the eye lids
272 h0000 
372 h0020discharge score 1
18 d0000 
28 d0000 
38 d0000 
mean24 - 72 h0.000.001.330.11 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.
Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed according to a OECD TG 405 conform and GLP compliant study. The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of three white Vienna rabbits. Exposure to the test susbstance produced conjunctival redness in 2/3 animals by all scoring intervals (24, 48 and 72 hours). One animal showed chemosis by the 24-hour scoring interval. The findings were reversible in all animals within 8 days after application. Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.