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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6-ethyl-2-toluidine
EC Number:
246-309-6
EC Name:
6-ethyl-2-toluidine
Cas Number:
24549-06-2
Molecular formula:
C9H13N1
IUPAC Name:
2-ethyl-6-methylaniline
Details on test material:
purity: 99.75%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White albino rabbit
TEST ANIMALS
- Source: Interfauna UK Ltd.
- Housing: single in steel mesh cage (typ III-hoch)
- Diet: standard diet "ssniff K 4"
- Water: ad libitum
- Acclimation period: at least 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10fold per hour
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h, 7 d
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight turbidity
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: discharge at 1 h, reversible within 24 h

Any other information on results incl. tables

RS-Freetext:
CORNEA: 
--slight turbidity: (3/3; mean score 0.7 of max.4; total area; 1-48 h;  reversible)
IRIS: no findings
CONJUNCTIVA: 
--slight redness (3/3; mean score 1.3 (range:1-1.7 of max.4); 1-72 h, reversible), 
--slight swelling (3/3; score 4 of max.4; 1 h; reversible)
--discharge (1/3; score 2 of max.3; 1 h; reversible)

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Executive summary:

A slightly irritating potential of 2 -ethyl-6 -methylaniline (MEA) was seen in a guideline study (OECD 405) with New Zealand White albino rabbits (Bayer 1989). The application of 100 µl MEA in the conjunctiva sac caused slight cornea reactions and an irritation of the conjunctivae. The observed effects were reversible; no effects were seen after 72 hours (Bayer 1989).