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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 26, 2015 to August 07, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in 2015 at recognised contract research organisation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dihydro-2,2,6-trimethylbenzaldehyde
EC Number:
204-133-7
EC Name:
2,3-dihydro-2,2,6-trimethylbenzaldehyde
Cas Number:
116-26-7
Molecular formula:
C10H14O
IUPAC Name:
2,6,6-trimethylcyclohexa-1,3-diene-1-carbaldehyde
Test material form:
other: Liquid
Details on test material:
Batch N°SC00013340
Purity 82.7%
Expiry date 20.10.2015

Test animals / tissue source

Species:
chicken
Strain:
other: ROSS 308
Details on test animals or tissues and environmental conditions:
Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129. Hungary
Chicken heads were collected after slaughter in a commercial abattoir from chickens which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to CiToxLAB Hungary Ltd. at ambient temperature at the earliest convenience.
After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at CiToxLAB Hungary Ltd. and processed within approximately 2 hours of collection.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
The test item was applied as supplied, no formulation was required.
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item was applied in a volume of 30 µL onto the entire surface of the cornea attempting to cover the cornea surface uniformly with the test item, taking care not to damage or touch the cornea.
Duration of treatment / exposure:
The time of application was observed, then after an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with 20 mL physiological saline at ambient temperature, taking care not to damage the cornea but attempting to remove all residual the test item if possible.
Duration of post- treatment incubation (in vitro):
approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Number of animals or in vitro replicates:
3
Details on study design:
After the zero reference measurements, the eye was held in horizontal position and 30 μL of SAFRANAL was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Run / experiment:
Mean maximum corneal swelling at up to 75 min
Value:
0
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
percent corneal swelling
Run / experiment:
Mean maximum corneal swelling at up to 240 min
Value:
0
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Run / experiment:
Mean maximum corneal opacity
Value:
0.67
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
fluorescein retention score
Run / experiment:
Mean fluorescein retention
Value:
0.67
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The results from all eyes used met the quality control standards. The negative control and positive control results were in line with historic data. This experiment was considered to be valid.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on this in vitro eye irritation in the isolated chicken eyes test with SAFRANAL, the test item is not classified as severe irritant and not classified as non-irritant.
Executive summary:

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (26th July 2013).

After the zero reference measurements, the eye was held in horizontal position and 30 μL of SAFRANAL was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 μL of 5% (w/v) Benzalkonium chloride solution. The negative control eye was treated with 30 μL of physiological saline (Salsol solution, NaCl 0.9% w/v).

No corneal swelling was observed during the four hour observation period. Corneal opacity change (severity 0.5 or 1) and fluorescein retention change (severity 0.5 or 1) was noted on all test item treated eyes. These results are slightly above the maximum threshold for a negative.

Based on this in vitro eye irritation in the isolated chicken eyes test with SAFRANAL, the test item is not classified as a severe irritant and not classified as non-irritant.