Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study already available
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method according to the Federal Register, Vol . 38, No. 187 (27.09.73), § 1500 .42 and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, p .51
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: M. GAUKLER (6050 Offenbach)
- Weight at study initiation: 2.56 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 µl
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING SYSTEM: Follows OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3 - 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: opacity of the cornea could not be scored after 72 h due to severe ulcerations
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h -8 d
Score:
0 - 1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: changes in the iris could not be scored after 72 h due to severe ulcerations
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 8d
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: redness of the conjuctivae could not be scored after 72 h due to severe ulcerations
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
In 2 out of 6 animals after 72 h and all animals after 8 d severe ulcerations were observed. Further oberservations were: grey/white nictating membrane, sticky eyes, severe suppuration, grey/white mucous membrane, blood.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Based on the findings of the study Dipropylenetriamine was judged corrosive to the eyes.
Executive summary:

Dipropylenetriamine was applied to conjunctival sac of the eyes of 6 Vienna White rabbits. Animals were observed after 24, 48 and 72 hours and up to 8 days after the treatment. The application caused corrosion (irreversible), predominantly expressed by severe corneal opacity.