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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older proprietary study conducted prior to development of guidelines and GLP, limited information available on methods but adequate for the purposes of hazard classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In vivo eye irritation study in rabbits, conducted prior to development of the guidelines
GLP compliance:
no
Remarks:
study conducted prior to development of GLP

Test material

Constituent 1
Reference substance name:
Amides, tall-oil fatty, N,N-di-Me
EC Number:
269-665-4
EC Name:
Amides, tall-oil fatty, N,N-di-Me
Cas Number:
68308-74-7
Molecular formula:
not applicable for UVCB
IUPAC Name:
Amides, tall-oil fatty, N,N-di-Me
Constituent 2
Reference substance name:
DMATO
IUPAC Name:
DMATO
Test material form:
other: liquid
Details on test material:
DMAD Lot 418 =90% DMTO

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were adult albino New Zealand White rabbits.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL undiluted test material was applied
Duration of treatment / exposure:
Not applicable - single treatment
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
9
Details on study design:
Rabbits were placed in a collar to prevent rubbing of the treated eye. The test substance (0.1 mL) was instilled into one eye, the other eye served as an untreated control. Reactions were assessed at 24, 48 and 72 hours after instillation. The test material was not washed from the eyes following instillation, however any test material residue/discharge was flushed from the eye prior to scoring. Reactions were evaluated according to the degree of damage caused to the cornea, iris and the bulbar and palpebral conjunctivae.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 24 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 24 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 24 hours
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 24 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 48 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 48 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 48 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 48 hours
Score:
0
Irritant / corrosive response data:
A score of 1 was assigned to 3 rabbits for conjunctival redness at the 24 hour time point. No other reactions were observed at the 24 hour reading. At 48 hours all readings were negative. Scores were not presented for the 72 hour time point.
Other effects:
No other effects reported.

Any other information on results incl. tables

No additional information available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the test material is considered to be non-irritating to the eye.
Executive summary:

The eye irritation potential of DMAD was evaluated in 9 New Zealand White rabbits. A quantity of 0.1 mL test material was instilled into one eye of the rabbits, the other eye remained untreated to serve as a control. Ocular reactions were evaluated at 24, 48 and 72 hours post-instillation; any residual test material or discharge was flushed from the eye prior to evaluations. The test material caused minimal conjunctival irritation in 3 of the 9 rabbits at 24 hours post-instillation. No other reactions were observed, and no signs of irritation were observed at the 48 hour time point. Based on the results of this study, the test material is considered to be non-irritating to the eye.