Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
July 26 to Sugust 31, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted for the notification in China where authorities do not accept non-animal nor read-across data for the endpoint eye irritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihexyl ether
EC Number:
203-987-8
EC Name:
Dihexyl ether
Cas Number:
112-58-3
Molecular formula:
C12H26O
IUPAC Name:
1-(hexyloxy)hexane
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 46 weeks (animal 1) and 54 weeks (animal 2)
- Weight at study initiation: 3.7 kg (animal 1) and 3.8 kg (animal 2)
- Housing: ABS-plastic or Noryl rabbit cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10x/h
- Photoperiod (hrs dark / hrs light): 12 dark/ 12 h light)

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 0.9 % NaCl
- Time after start of exposure: after 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
- Lesions and clinical observations: none

Any other information on results incl. tables

Animal no. 1 showed conjunctival redness score 1 from 1 hour to 24 hours after application. Chemosis score 1 was observed in this animal 1 hour after application.

Application of the test item in the eye of animal no. 2 led to conjunctival redness score 2 after 1 hour and decreased to score 1 24 hours post-application. Chemosis score 1 was recorded 1 hour after application. In both animals the effects were reversible within up to 48 hours post-application.

Neither mortalities nor significant clinical signs of toxicity or local effects were observed. However, animal no. 1 reacted very sensitive 1 hour after application, when touching the treated eye.

Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, the substance dihexyl ether is not irritating to the eyes.
Executive summary:

An acute eye irritation study was performed according to OECD Test Guideline 405.

After the application into the eyes of two male NZW rabbits the test item produced slightly irritant but not corrosive effects in two animals.

Animal no. 1 showed conjunctival redness score 1 from 1 hour to 24 hours after application. Chemosis score 1 was observed in this animal 1 hour after application.

Application of the test item in the eye of animal no. 2 led to conjunctival redness score 2 after 1 hour and decreased to score 1 24 hours post-application. Chemosis score 1 was recorded 1 hour after application. In both animals the effects were reversible within up to 48 hours post-application.

Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.

Neither mortalities nor significant clinical signs of toxicity or local effects were observed. However, animal no. 1 reacted very sensitive 1 hour after application, when touching the treated eye.

Based on the result of this study, the substance dihexyl ether is not irritating to the eyes.