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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-05-20 till 2015-06-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 438 guideline study in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment

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

1
Chemical structure
Reference substance name:
Methyl o-toluate
EC Number:
201-932-2
EC Name:
Methyl o-toluate
Cas Number:
89-71-4
Molecular formula:
C9H10O2
IUPAC Name:
methyl o-toluate
Test material form:
liquid
Specific details on test material used for the study:
Lot no: SM14116260
Expiry date: 24 November 2015
Physical state: Colourless liquid

Test animals / tissue source

Species:
other: eyes of male or female chickens (ROSS, spring chickens)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Slaughterhouse v.d. Bor, Nijkerkerveen, The Netherlands
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: approximately 1.5 - 2.5 kg
- Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
- The preparation and validation of the eyes prior to the ICE-test were all according to OECD guideline 438.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Positive controls: Benzalkonium Chloride. Negative control: Phosphate buffered saline (PBS).
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 30 µL
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
0, 30, 75, 120, 180, and 240 minutes
Number of animals or in vitro replicates:
3 eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were rinsed with 20 mL saline
- Time after start of exposure: 10 seconds

SCORING SYSTEM: According to OECD 438 guideline.

TOOL USED TO ASSESS SCORE: All examinations were carried out with the hand-slit lamp microscope. Fluorescein retention was only scored at approximately 30 minutes after treatment.

CONTROLS: A negative control (30 µL physiological saline) and 3 positive controls (30 µL Benzalkonium Chloride 5%) were included.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Run / experiment:
mean
Value:
5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
mean
Value:
2.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
mean
Value:
0.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

In vivo

Irritant / corrosive response data:
Slit-lamp examination: Ylanganate caused very slight corneal swelling (5%), moderate to severe opacity (mean score of 2.5) and very slight or slight fluorescein retention (mean score of 0.8). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants.

Microscopic examination: Microscopic examination of the corneas treated with Ylanganate did not reveal any abnormalities. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. The positive control BAC 5% caused severe erosion, slight vacuolation (one cornea; low region) of the epithelium, the epithelium partly detached from the basement membrane (two corneas), and endothelial necrosis (two corneas).

Applicant's summary and conclusion

Interpretation of results:
other: Eye irritant Category 2 (irritant)
Remarks:
according to the CLP Regulation EC 1272/2008 and its updates
Conclusions:
Under the test conditions (OECD 438 and GLP) the test substance is considered to be an eye irritant
Executive summary:

In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused very slight corneal swelling (5%), very slight or slight to moderate opacity (mean score of 2.5) and very slight fluorescein retention (mean score of 0.8). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with the test substance did not reveal any abnormalities. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. The positive control BAC 5% caused severe erosion, slight vacuolation (one cornea; low region) of the epithelium, the epithelium partly detached from the basement membrane (two corneas), and endothelial necrosis (two corneas). Based on these results, the test substance is considered to be an eye irritant.