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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
An in vivo study from before 2016 is used for asssessing eye irritation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1991-12-10 to 1991-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The information is used for read across to Oenanthic ether.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Substance type: pure active substance
- Molecular formula (if other than submission substance): C15 H26 O2
- Molecular weight (if other than submission substance): 236.369
- Smiles notation (if other than submission substance): O=C1CCCCCCCCCCCCCCO1
- Storage condition of test material: Approximately 4°C under nitrogen in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex - England
- Age at study initiation: not mentionned in the study report
- Weight at study initiation: 2.7, 3.4, 2.8 & 3.2 kg
- Housing: The animals were individually housed in grid bottomed metal cages.
- Diet: Free access to antibiotic-free pelleted diet, SQC Stanrab (Special Diets Services, Witham, Essex). (Quality checked)
- Water: Free access via an automatic watering system were freely available. (Quality checked)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 22°C (On 3 occasions the temperature fell below the protocol specified range, the temperature of 15°C being recorded on only one of these occasions. These deviations were considered not to have affected the outcome of the study)
- Humidity (%): 37 to 59%
- Air changes (per hr): not mentioned in the study report
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Dec 1991 2004 To: 20 Dec 1991

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few second immediately after treatment, to prevent loss of the test material, and then released. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. One rabbit was dosed initially to assess the severity of irritation or pain. As the response to treatment was considered acceptable the remaining three animals were then dosed.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An assessment of the initial pain reaction was made immediately after administration of the test material.
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: NA

TOOL USED TO ASSESS SCORE: animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour).

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:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal: # 2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritant / corrosive response data:
One hour after dosing, conjunctival discharge and hyperaemia was apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
other: Not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
In an OECD guideline 405 study conducted in compliance with GLP, the test substance is considered to be not irritating to the eye.
Executive summary:

In an eye irritation study performed according to GLP and OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. As such, the substance does not need to be classified for eye irritation.