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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1/24/1983 to 2/7/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-like (QA signature), guideline study; restriction due to study being terminated prior to all effects had resolved.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16CFR 1500.42- Federal Hazardous Substances Act Regulations
Deviations:
no
GLP compliance:
yes
Remarks:
Study predates GLP regulations, but QA signature is available.

Test material

Constituent 1
Reference substance name:
Dihydro-3-(tetrapropenyl)furan-2,5-dione
EC Number:
247-781-6
EC Name:
Dihydro-3-(tetrapropenyl)furan-2,5-dione
Cas Number:
26544-38-7
IUPAC Name:
3-dodec-2-en-1-yldihydrofuran-2,5-dione
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Housing: The animals were housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publication No. 80-23). 1 rabbit/cage (stainless steel with elevated wire mesh flooring).
- Diet (e.g. ad libitum): Wayne 15% Rabbit Ration was provided ad libitum
- Water (e.g. ad libitum): tap water was provided ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 60-75°F
- Humidity (%): 40-45%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7 and 14 days following instillation of test material into the eyes.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.

SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: All scores were 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: all scores were 0
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 14d
Irritant / corrosive response data:
In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the rabbits (6 animals).
The mean Draize scores (24, 48 and 72 h) were:
Cornea = 0
Iris = 0
Conjunctivae – redness = 1.7
Chemosis = 2.5
 
The test substance produced ocular irritation which was not cleared until day 14.

Any other information on results incl. tables

Draize Scores

Animal #

1

2

3

4

7

14

Conjunctivae-chemosis

 

 

 

 

 

 

1

3

3

3

2

1

1

2

4

2

2

2

1

1

3

2

2

1

1

1

1

4

4

3

3

3

3

1

5

2

2

1

1

1

1

6

3

2

3

2

1

1

Conjunctivae-redness

 

 

 

 

 

 

1

2

2

1

1

1

1

2

2

2

1

1

1

0

3

2

2

2

1

1

0

4

2

2

2

2

2

1

5

2

2

1

2

1

1

6

2

2

1

1

0

0

Cornea

 

 

 

 

 

 

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

0

0

0

Iritis

 

 

 

 

 

 

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Category 2 Criteria used for interpretation of results: EU
Conclusions:
Tetrapropenyl succinic anhydride (TPSA), a category member, was tested for eye irritation in rabbits according to a US test guideline, comparable to the OECD 405. The substance is classified as irritating to the eyes according to Regulation EC No. 1272/2008. Data can be read-across among members of the C8-12 Alkenyl Succinic Anhydrides Category, based on common functional groups, similar break-down products and potency patterns among carbon-chain length. This is adequate to fulfill the information requirements, to be the basis for classification and labelling decisions, and for risk assessment.