Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize procedure
Principles of method if other than guideline:
New Zealand female rabbits were used to evaluate the eye irritation potential of fragrance raw materials according to the Draize procedure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Nex Zealand

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
unspecified; substance was not washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
Scoring at: 24, 48, 72 hours, 4 days and 7 days

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks on result:
other: very slight conjunctival redness following treatment with linalyl acetate, which returned to normal within one day
Remarks:
100%: no effects; Mean score day 1: 0

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
slight and reversible (<7 days) eye irritation potential can be attributed to linalyl acetate.
Executive summary:

The NCS is composed of several identified constituents, so it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the eye irritation / corrosion potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests.

But one of its constituents is classified as eye irritant (Linalyl acetate at 67%) and none other constituents is assessed corrosive for eyes.

The single constituent is present above the CLP generic concentration limit of 10% that triggers classification of the mixture. Therefore, the registered substance is classified as a eye irritant substance without further testing according to the Regulation (EC) No 1272/2008.


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