3,4 XYL

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study in compliance with specific test guidelines, well documented, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: CFR/USA, Title 16, Section 1500.42

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,5-xylenol

EC Number:

203-606-5

EC Name:

3,5-xylenol

Cas Number:

108-68-9

Molecular formula:

C8H10O

IUPAC Name:

3,5-dimethylphenol

Details on test material:

- Name of test material (as cited in study report): Produkt-Nr. 111.184 (= 3,5-dimethyl phenol)
- Molecular formula (if other than submission substance): C8H10O
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: solid
- Analytical purity: specified as "pure"
- Impurities (identity and concentrations): no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: J. Scheele, Werl/Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: mesh metal cage
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Air-conditioned room
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

TEST MATERIAL
- Amount(s) applied: 100 mg


TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

not rinsed

Observation period (in vivo):

24 h, 48 h, 72 h and 7 d after instillation

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: Draize numerical scores (recommendation of the Food and Drug Officials of USA 1959)
- Cornea: opacity (A), area affected (B) => basis of calculation A x B x 5 (Draize Score 1)
- Iris: irritation effect, response to light (A) => basis of calculation A x 5 (Draize Score 2)
- Conjunctivae: erythema (A), oedema/chemosis (B), discharge (C): => basis of calculation (A + B + C) x 2 (Draize Score 3)

- EVALUATION: Reading after 24, 48, and 72 h and
calculation of an "Irritation Score" = Sum of "Draize Scores" at the three time points for each animal
divided by 18 ( 3 time points, 6 animals).

The ranking system of the "Irritation Score" was as follows
(based on ETAD recommendation):
0 - 10 not irritating
11 - 25 slightly irritating
26 - 56 moderately irritating
57 - 110 severely irritating

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein (not specified)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

(6 animals)

Time point:

other: 24, 48, and 72 h

Score:

58.4

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Details: see Attached document

Irritant / corrosive response data:

Cornea with diffuse and partly opalescent areas (6/6 animals);
iris with reduced response to light, increased injection of blood vessels (2/6 animals);
conjunctivae and eyelids swollen, erythematous, nictitating membrane covered with blebs, increased discharge (6/6 animals).
No significant reversibility of effects during the observation period.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: code of Federal Regulations, Title 16 Section 1500.42

Conclusions:

The average irritation index was 58.4 and the substanvce was evaluated as severely irritating in accordance with the recommednations of ETAD.

Executive summary:

The eye irritancy of 3,5 xylenol was studies in 6 New Zealand white rabbits using the method of the US consumer product safety commission (code of Federal Regulations, Title 16 Section 1500.42). The animals were given a single instillation of 100mg into the conjunctival sac of one eye and the effects were assessed at 24, 48 and 72 hrs after instillation. The effects were evaluated using the Draize scoring system in accordance with the recommendations of ETAD. In all rabbits, irritation of the conjunctivae with reddening, chemosis and ocular dishcarge were present at all time points as was corneal clouding, the effects being only slightly reversible during the 3 -day observation period. The iris showed injected vessels. The average irritation index was 58.4 and the substanvce was evaluated as severely irritating in accordance with the recommednations of ETAD.