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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:
October 31, 1986 to November 25, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD Guideline 405 and EU Method B.5. in compliance with GLP
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Komperlan KD (CAS 90622-74-5)
- Purity > 95%

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- 4 males
- Source: HM/Fa. Thomae, Germany
- Average bodyweight at test start: 2,630 g

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.01 ml (low volume method)
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
4
Details on study design:
0.01 mL test substance carefully applied in undiluted form into the lower lid of the right eye of the test animals.
The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize appraisal method (J.H. Draize, Appraisal of the safety of chemicals in foods, drugs and cosmetics. Ass. of Food and Drug Officials of the US, pp 49-52 (1959)).

Results and discussion

In vivo

Irritant / corrosive response data:
On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible.
Irreversible effects were also noted in the iris of one animal.
Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl) was considered to be highly irritating to the rabbit eye.
Executive summary:

A study was performed to assess the eye irritation potential of amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl) according to OECD 405 and EU guideline B.5 in compliance with GLP.

Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period.

Under the test conditions, amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl) was considered to be highly irritating to the rabbit eye.