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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
3/5/91-2/9/91
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study to OECD Guideline and subject to GLP audit

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Rosin, fumarated
EC Number:
266-040-8
EC Name:
Rosin, fumarated
Cas Number:
65997-04-8
IUPAC Name:
Rosin, fumarated
Details on test material:
- Name of test material (as cited in study report): rosin, fumarated
- Substance type: Chemically modified UVCB
- Physical state: solid
- Analytical purity:assumed 100% (Certificate of analysis provided)
- Purity test date: 26.3.91
- Lot/batch No.:260391
- Stability under test conditions: assumed stable
- Storage condition of test material: ambient temp in amber glass jar

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex
- Age at study initiation: 4.5 mo
- Weight at study initiation: 3.51 kg
- Housing: suspended stainless steel cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum):ad lib
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-19 deg C
- Humidity (%): 50-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 3/06/1991-3/06/1991

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Instilled and eye held closed for 1 second
Observation period (in vivo):
5 h
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM:
Standard EU scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp (ophthalmoscope)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
other: Discharge
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 5 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 5 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 5 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 5 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: 5 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritant / corrosive response data:
Classifiable 'severe eye irritant' (DSD) or Category 1 eye irritant (GHS).

Any other information on results incl. tables

In view of the result the substance was not administered to further animals.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Substance is a severe eye irritant
Executive summary:

In a test on one animal, terminated at 5 h after instillation, the substance was found to be a severe eye irritant. Further testing was therefore not warranted.