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Toxicological information

Eye irritation

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

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:
1-(2-bromoethoxy)-2-methoxybenzene
EC Number:
402-010-4
EC Name:
1-(2-bromoethoxy)-2-methoxybenzene
Cas Number:
4463-59-6
Molecular formula:
C9H11BrO2
IUPAC Name:
1-(2-bromoethoxy)-2-methoxybenzene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft., address: 2173, Kartal, Császár út 135, Hungary
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2680-2740 g
- Housing: Animals were housed individually in metal cage
- Diet (e.g. ad libitum): The animals received C.HYF rabbit mixed diet produced by Cargill Takarmány Zrt., 5300 Karcag, Madarasi út 0399, Hungary, ad libitum.
- Water (e.g. ad libitum): The animals received C.HYF rabbit mixed diet produced by Cargill Takarmány Zrt., 5300 Karcag, Madarasi út 0399, Hungary, ad libitum.
- Acclimation period: 5 days in first animal, 6 days in second animal and 7 days in third animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr):above 10 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item was used for the study in undiluted form, as a single dose.


Duration of treatment / exposure:
The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.

SCORING SYSTEM:
Draize (1979) and OECD 405 (02 October 2012)

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0 - 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application.
One hour after treatment some hyperemic blood vessels (score 1) were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in animal No.: 4687.
24 hours after treatment some hyperemic blood vessels (score 1) were observed in all animals.
48 hours after treatment some hyperemic blood vessels (score 1) were observed in two animals (No.: 4687, 4682). Animal No.: 4691 became free of symptoms.
72 hours after treatment all animals were free of symptoms.
72 hours after the treatment the study was finished.
During the study the control eyes of animals were symptom-free.
Detailed eye irritation results are shown in Appendix I.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00
redness : 0.66, 0.66, 0.33
chemosis : 0.00, 0.00, 0.00
discharge : 0.00, 0.00, 0.00
No systemic toxicity was observed on the day of the treatment and during the 3-day observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress was not observed during the study.

Applicant's summary and conclusion

Interpretation of results:
other: not irritant
Conclusions:
In conclusion, test item Bromethoxy-qvajacol (CVD 21) applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which was fully reversible within 72 hours.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.