Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline-compliant investogation of ocular irritation performed as part of a larger investigation of toxicokinetics.

Data source

Reference
Reference Type:
publication
Title:
Absorption, Distribution and Excretion of Terephthalic Acid and Dimethyl Terphthalate
Author:
Moffitt, A.E., Clary, J.J., Lewis, T.R., Blanck, M.D. and Perone, V.B.
Year:
1975
Bibliographic source:
American Industrial Hygiene Association Journal, 36(8), 633-41 (1975)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US FDA Test for eye irritants (21CFR Part 191), 1964
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Albino rabbits: no further data reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
A single dose of 50 mg DMT was instilled into the conjunctival sac one eye of 8 rabbits. The eyes were washed with water after five minutes or 24 hours.
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
8
Details on study design:
A single dose of 50 mg DMT was instilled into the conjunctival sac one eye of 8 rabbits. The eyes were washed with water after five minutes or 24 hours.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: All
Score:
0
Max. score:
0
Remarks on result:
other: No effects are reported
Irritant / corrosive response data:
No evidence of ocular damage was seen in this study.
Other effects:
The toxicokinetics of the substance following ocular administration were also investigated and are reported elsewhere.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No evidence of ocular irritation was reported in this study.
Executive summary:

In a guideline-compliant study, a single dose of 50 mg DMT was instilled into the conjunctival sac one eye of 8 rabbits. The eyes were washed with water after five minutes or 24 hours. No evidence of ocular irritation was reported.