1,2-diethoxybenzene

Eye irritation

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

1,2-diethoxybenzene

EC Number:

218-089-1

EC Name:

1,2-diethoxybenzene

Cas Number:

2050-46-6

Molecular formula:

C10H14O2

IUPAC Name:

1,2-diethoxybenzene

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

Results

Results 1

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)

Results 2

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)

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: see AOI

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: see AOI

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: see AOI

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: see AOI

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 2 (irritating to eyes) based on GHS criteria

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 2, H319 according to the CLP Regulation (EC) N° 1272/2008 and as Xi-R36 according to the Directive 67/548/EEC.