Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Draft study report
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Batch No.: FAB-15052015
Purity: 76.6% (sum of the three main constituents)
Name of test material (as cited in study report): Reaction mass of beta-phellandrene and d-limonene and l-limonene
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 14 May 2016

Test animals / tissue source

Species:
human
Strain:
other: reconstructed human Cornea-like Epithelium
Details on test animals or tissues and environmental conditions:
EpiOcular TM tissue Model OCL-212 supplied by MatTek

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE was applied as supplied at the dose of 50 µL
Duration of treatment / exposure:
30 minutes
Duration of post- treatment incubation (in vitro):
A 12-minute post exposure immersion period at room temperature and 1 hour and 54 minutes post exposure incubation at standard culture conditions.
Number of animals or in vitro replicates:
2 replicates.

Results and discussion

In vitro

Results
Irritation parameter:
other: percent tissue viability
Value:
82.94
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
percent tissue viability = 31.99%

In vivo

Irritant / corrosive response data:
REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE IS CONSIDERED AS NON IRRITANT AND NON CORROSIVE

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE does not require classification for eye irritation or serious eye damage. Also, the test item does not require classification for eye irritation or serious eye damage according to UN GHS.
No hazard statement and no signal word are required.
Executive summary:

In a GLP study conducted according to OECD 492 guideline, the irritant potential of reaction mass of beta-phellandrene and D-limonene and L-limonene was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium-(RhCE) when exposed to 50 µL the test substance for 30 min. The mean percent tissue viability of the RhCE replicates treated with the test item reaction mass of beta-phellandrene and D-limonene and L-limonene was 82.94% versus 31.99% in the positive control (Methyl acetate). In conclusion, under experimental conditions adopted and in accordance with the Regulation EC N° 1272/2008, the test item does not require classification as eye irritant or serous eye damage according to UN GHS. No hazard statement or signal word are required.