Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published data, it failed details on experimental conditions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the ocular-irritation potential of 56 compounds.
Author:
J.P.Guillot, J.F. Gonnet, C. Clement, L. Caillard, R.Truhaut.
Year:
1982
Bibliographic source:
Fd Chem. Toxic, vol.20, 573-582.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Tests performed according to 3 methods: Cosmetics and toileteries (Journal Official 21 April 1973, p. 3862; ibid 5 June 1973, p. 3953), AFNOR (1979) and OECD (1979).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): o-Diethyoxybenzene
- Substance type: no data
- Physical state: colourless liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: TIL 4626
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Roucher SA, Couhé.
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

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

VEHICLE: none
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
Observations were recorded at 1 hr and 1, 2, 3, 4 and 7 days after instillation.
Number of animals or in vitro replicates:
12 males:
first group of 6 males without rinsing and secong group of 6 males with rinsing after 30s.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing carried out with Dacryoserum (from Chibert Laboratories, Paris)

SCORING SYSTEM:
According to an evaluation scale adapted from Kay & Calandra (1962). At each observation time, lesions of the conjunctiva, iris and cornea were scored separately.
The sum of these scores being the individual ocular irritation index (IOI) for each animal. Calculation of the mean (and standard deviation) of the IOI values obtained at any one time gave the mean ocular irritation index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI), which was used for the preliminary classification of a substance in one of six categories between "non-iritant" and extremely irritant (see Table 7.3.2/1)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Acute ocular irritation index (AOI)
Basis:
mean
Remarks:
(without rinsing)
Time point:
other: 1 h
Score:
16.17
Max. score:
110
Reversibility:
fully reversible
Remarks:
Day 3
Remarks on result:
other: MOI: 0 (Day 4)
Irritation parameter:
other: Acute ocular irritation index (AOI)
Basis:
mean
Remarks:
(rinsing 30s after instillation)
Time point:
other: 1h
Score:
13
Max. score:
110
Reversibility:
fully reversible
Remarks:
Day 3
Remarks on result:
other: MOI: 1 (Day 2)
Irritant / corrosive response data:
No data
Other effects:
No data

Any other information on results incl. tables

No data.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: other: AFNOR (1982)
Conclusions:
Under the test conditions of this study, 1,2-diethoxybenzene is irritating to rabbits on ocular application without rinsing and slightly irritating when rinsed.
Executive summary:

In a primary eye irritation study (J.P. Guillot and al, 1982), using a procedure that complied with the main requirement of three methods (OECD, AFNOR, Cosmetic and toileteries), 0.1 mL of 1,2 -diethoxybenzene was instilled into the conjunctival sac of the eye of treated groups of 6 New Zealand white rabbits (males) (eyes washed and unwashed). Scoring was assessed at 1 hr and 1, 2, 3, 4, 7 days post instillation. Irritation was scored by the method according AFNOR.

- As the Acute Ocular irritation Index (AOI) = 16.7 and the Mean Ocular irritation Index (MOI) = 0 (Day 4), 1, 2 -diethoxybenzene was considered as irritating to rabbits on ocular application without rinsing according to AFNOR scale.

- As the Acute Ocular irritation Index (AOI) = 13 and the Mean Ocular irritation Index (MOI) = 1 (Day 2), 1, 2 -diethoxybenzene was considered as slightly irritating to rabbits on ocular application when rinsed according to AFNOR scale.

In conclusion, based on these results, 1,2 -diethoxybenzene is considered as irritating to eyes and classified into category 2A, H319 according to the CLP Regulation (EC) N° 1272/2008 and as Xi-R36 according to the Directive 67/548/EEC.