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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
before 22 February 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Standard methods used but details of methods and results not available. For read-across justification see Section 13.

Data source

Reference
Reference Type:
other: Diundecyl phthalate letter summary toxicity data
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not specified
Principles of method if other than guideline:
Instillation of 0.1 ml of undiluted DUP into rabbit's eye. Observations scored at 1, 24 & 48h after instillation.
Probably FHSA test method used.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diundecyl phthalate
EC Number:
222-884-9
EC Name:
Diundecyl phthalate
Cas Number:
3648-20-2
Molecular formula:
C30H50O4
IUPAC Name:
diundecyl benzene-1,2-dicarboxylate
Details on test material:
Not reported

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
Not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single instillation followed by observation of effects for 48 hours
Observation period (in vivo):
48H
Number of animals or in vitro replicates:
6 based on no. of possible observations for conjunctival irritation
Details on study design:
Instillation of 0.1 ml of undiluted DUP in rabbit's eye. Observations scored at 1, 24 & 48h after instillation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: all animals
Time point:
other: 1h
Score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: total score possible =110
Irritation parameter:
conjunctivae score
Basis:
other: all animals
Time point:
other: 24h
Score:
3.3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: total score possible =110
Irritation parameter:
conjunctivae score
Basis:
other: all animals
Time point:
other: 48
Score:
0
Reversibility:
fully reversible
Remarks:
within 48h
Remarks on result:
other: total score possible = 110
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 48h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 48h
Score:
0
Max. score:
0
Irritant / corrosive response data:
minimal conjunctival irritation with a score of 4 out of a possible 110
Other effects:
Not reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Slight conjuctival irritation observed following exposure. Recovery within 48 hours
Executive summary:

Slight conjuctival irritation observed following exposure. Recovery within 48 hours.