2-(chloromethyl)-4-methylquinazoline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-11-27 to 2006-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

476-280-7

EC Name:

-

Cas Number:

109113-72-6

Molecular formula:

C10 H9 Cl N2

IUPAC Name:

2-(chloromethyl)-4-methylquinazoline

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: Solid (powder); Off-white with yellow spherical particles

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (Europe) Laboratories, Inc. Toxi Coop Ltd. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats
- Weight at study initiation: Male: 236 - 267g; Female: 201 - 221g
- Housing: Individual caging (1 animal/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: approx. 10 %
- Type of wrap if used: Sterile gauze pads

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with water was performed
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes (test item in its original form, moistened with 0.5 ml of distilled water)
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of exposure:

24 h

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 0 (beginning of the experiment), on day 7 and on day 14; clinical examination: day of treatment 1h and 5h after the administration and once each day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the test animals died.

Clinical signs:

other: There were no clinical signs. The behaviour and physical condition of animals were considered to be normal. CD 605 caused erythema on the treated skin of male (3/5) and female (5/5) rats, which recovered on days 3 and 4.

Gross pathology:

No macroscopic alterations due to the effects of the test item were found. Gross necropsy revealed pinprick-sized haemorrhages in the lungs both in males (1/5) and in female animals (2/5). The haemorrhages in the lungs were due to the method of anaesthesia and exsanguinations are also observable in untreated animals after anaesthesia.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not meet the criteria for classification as a LD50 of > 2000 mg/kg bw was determined.