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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
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

Constituent 1
Chemical structure
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.