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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically defensible or guideline method was used, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Guideline:
other: US Federal Hazardous Substance Act
Deviations:
not specified
Remarks:
for further details see below
Principles of method if other than guideline:
30 mg test compound was applied as finely ground sample (Dosage equivalent to 0.1 ml)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxylic acids, di-, C4-6
EC Number:
271-678-5
EC Name:
Carboxylic acids, di-, C4-6
Cas Number:
68603-87-2
Molecular formula:
C5H8O4, C4H6O4, C6H10O4
IUPAC Name:
Carboxylic acids, C4-6 di-
Details on test material:
Dibasic Acid Concentrate; 30 mg test compound was applied as finely ground sample (Dosage equivalent to 0.1 ml)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not determined
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not determined
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not determined
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
10 - <= 15
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
10 - <= 40
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0 - <= 5
Max. score:
80
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
5 - <= 10
Max. score:
10
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
5 - <= 10
Max. score:
10
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
5 - <= 10
Max. score:
10
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
14 - <= 16
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
14 - <= 16
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
14 - <= 16
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Other effects:
Day 21: Slight ulceration in three instances, slight to moderate discharge; nictitating membrane not visibel

Any other information on results incl. tables

The individual scores of 3 animals were shown; the other three treated animals show comparable effects.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Criteria used for interpretation of results: other: Federal Hazardous Substance Act
Conclusions:
Test material was irritating to the eye; the observed effects were not fully reversible within 21 days.
Executive summary:

In an eye irritation study performed again according to the US Federal Hazardous Substance Act in the same laboratory six rabbits were dosed with 30 mg dicarboxylic acid mixture for 24 hours. Severe erythema and slight edema and copious discharge was observed 10 minutes after installation. After 1 and 24 hour the following observations were recorded: translucent to opalescent areas of corneal cloudless, iris showed sluggish/no reaction to light, slight to moderate edema, copius discharge. The effects gradually improved between 48 and 168 hours but were not reversible after 21 days (slight ulceration in three instances, slight to moderate discharge; nictitating membrane not visible).