Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-698-8 | CAS number: 27859-58-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 January 1983 to 10 March 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR.
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (tetrapropenyl)succinic acid
- EC Number:
- 248-698-8
- EC Name:
- (tetrapropenyl)succinic acid
- Cas Number:
- 27859-58-1
- Molecular formula:
- C16H28O4
- IUPAC Name:
- 2-(C12-rich-branched olefins from propene oligomerization)-1,4-butanedioic acid
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Product as manufactured in White Oil.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Specified only as young adults
- Weight at study initiation:
- Housing: Stainless steel with elevated wire mesh flooring 1 rabbit/cage
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60 to75 °F
- Humidity (%):40 to 45 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of the test material was dosed as the test material was supplied (unchanged, no vehicle).
- Duration of treatment / exposure:
- 21 days; the test material was not washed from the eyes.
- Observation period (in vivo):
- The treated eyes were examined at 1, 2, 3, 4, 7, 14 and 21 days following installation of the test material into the eyes.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test material was not washed from the eyes.
- Time after start of exposure: Not applicable
SCORING SYSTEM: The Draize scale
TOOL USED TO ASSESS SCORE: None specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- The test material was irritating, with some parameters not returning to normal within the 21 days observation period.
Any other information on results incl. tables
Individual Daily Scores
Rabbit no. |
Tissue and item |
Readings |
||||||
Day |
||||||||
1 |
2 |
3 |
4 |
7 |
14 |
21 |
||
1 |
Corneal opacity |
3 |
2M |
2M |
2 |
2P |
2P |
3P |
Iris |
2++ |
0 |
0 |
1 |
1 |
0 |
0 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
2 |
1 |
0 |
|
Conjunctival chemosis |
4 |
4 |
4 |
4 |
2 |
1 |
1 |
|
2 |
Corneal opacity |
2 |
2M |
2M |
1 |
1 |
2 |
4 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctival redness |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
|
Conjunctival chemosis |
4 |
4 |
4 |
4 |
3 |
2 |
2 |
|
3 |
Corneal opacity |
2M |
1M |
2M |
2 |
1P |
2 |
4P |
Iris |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
|
Conjunctival redness |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
|
Conjunctival chemosis |
4 |
4 |
4 |
4 |
2 |
2 |
3 |
|
4 |
Corneal opacity |
2M |
1M |
1M |
2 |
2P |
1P |
2 |
Iris |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
|
Conjunctival redness |
3 |
3 |
3 |
2 |
1 |
1 |
0 |
|
Conjunctival chemosis |
4 |
4 |
4 |
3 |
3 |
3 |
1 |
|
5 |
Corneal opacity |
2M |
1M |
1M |
2M |
1 |
0P |
0 |
Iris |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
|
Conjunctival redness |
3 |
3 |
3 |
2 |
1 |
1 |
0 |
|
Conjunctival chemosis |
4 |
4 |
4 |
4 |
1 |
1 |
1 |
|
6 |
Corneal opacity |
1 |
1M |
1M |
1 |
1P |
2P |
2P |
Iris |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
|
Conjunctival redness |
3 |
3 |
3 |
3 |
2 |
1 |
0 |
|
Conjunctival chemosis |
4 |
4 |
4 |
4 |
2 |
1 |
1 |
|
M = Mucous
P = Pannus
++ Maximum score assigned for iris since iris was not visible due to maximum corneal opacities.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the study, the test substance was determined to be an eye irritant.
- Executive summary:
A study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits.
The methods employed in the testing, evaluation and in the grading of the test material are similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR.
Six healthy young adult albino rabbits were used in this study. 0.1 mL of the test material was instilled into one eye of the test animals while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
The treated eyes were examined at one, two, three, four, seven, fourteen and twenty-one days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Seale of Scoring Ocular Lesions.
Under the conditions of the study, the test material was shown to be an eye irritant (Category 1).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
