Registration Dossier

Toxicological information

Eye irritation

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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

Reference
Name:
Unnamed
Type:
Constituent
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.