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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 24 May 2012 to 01 June 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
IUPAC Name:
Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
Constituent 2
Reference substance name:
100545-48-0
Cas Number:
100545-48-0
IUPAC Name:
100545-48-0
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.62 or 3.01 kg and were 12 to 20 weeks old. After an acclimatisation period of at least 5 d each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23Ā°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least 15 changes/h and the lighting was controlled by a time switch to give 12 h continuous light (06:00 to 18:00) and 12 h darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance (which was found to weigh approximately 66 mg)
- Concentration: Undiluted

Duration of treatment / exposure:
Duration of treatment same as observation period.
Observation period (in vivo):
The eyes were examined for any ocular reaction approximately 1, 24, 48, and 72 h after the treatment.

Number of animals or in vitro replicates:
Two
Details on study design:
PROCEDURE:
Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 mL of the test substance, which was found to weigh approximately 66 mg (as measured by gently compacting the required volume into an adapted syringe) 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 about one second immediately after treatment, to prevent loss of the test substance, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test substance, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize scale for scoring ocular Irritation (Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Based on Draize scoring method
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Based on Draize scoring method
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Based on Draize scoring method
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Based on Draize scoring method
Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
- Minimal conjunctival irritation was noted in both the animals 1 and 24 h after treatment and in one animal at the 48-h observation. However, these effects were reversible within 48 h in one animal and within 72 h in the other animal.


See below tables for further details.
Other effects:
Only one of the animal showed an expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1: Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex  72058 Male  72080 Male
Initial pain reaction = 1  Initial pain reaction = 1
Time after treatment  1 h 24 h 48 h 72 h 1 h 24 h 48 h 72 h
CORNEA                 
E = Degree of opacity  0 0 0 0 0 0 0 0
F = Area of cornea involved  0 0 0 0 0 0 0 0
Score (E x F) x 5  0 0 0 0 0 0 0 0
IRIS                 
D  0 0 0 0 0 0 0 0
Score (D x 5)  0 0 0 0 0 0 0 0
CONJUNCTIVAE                 
A = Redness  1 1 0 0 1 1 1 0
B = Chemosis  1 0 0 0 1 0 0 0
C = Discharge  1 0 0 0 1 0 0 0
Score (A + B + C) x 2  6 2 0 0 6 2 2 0
Total Score  6 2 0 0 6 2 2 0

Table 2: Individual Total Scores and Group Mean Scores for Ocular Irritation

 Rabbit Number and Sex   Individual total scores at: 
1 h 24 h 48 h 72 h
 72058 Male   6   2   0   0 

 72080 Male 

 6   2   2   0 
 Group Total   12   4   2   0 
 Group Mean Score   6.0   2.0   1.0   0 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test substance produced minimal conjunctival irritation which was reversible within 72 h.
Executive summary:

An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance in New Zealand White rabbits according to the EU Method B.5 and OECD Guideline 405 in compliance with GLP.

A volume of 0.1 mL of test substance (i. e, 66 mg) was placed into the conjunctival sac of the right eye of two New Zealand White rabbits without irrigation. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 h following treatment according to the Draize scoring method. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was seen in both animals 1 and 24 h after treatment and in one animal at the 48 h observation. These effects were reversible within 48 h in one animal and within 72 h in the other.

In conclusion, under the conditions of the study, the test substance produced minimal conjunctival irritation in rabbits which was reversible within 72 h