9,9-bis-(methoxymethyl)fluorene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EEC Directive 92/69/EEC, dated 31 July 1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Febraury 24, 1992

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Donor C20

IUPAC Name:

Donor C20

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-6 weeks
- Weight at study initiation: mean 201
- Housing: stainless steel cages, fitted with wire-screen floor and front
- Diet (e.g. ad libitum): standard rodent diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50-70%
- Air changes (per hr): ca. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 January 1997 To: 4 February 1997

Administration / exposure

Type of coverage:

occlusive

Vehicle:

maize oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 x 5 cm
- % coverage: at least 10% of total body surface
- Type of wrap if used: plastic foil, adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residues removed with water
- Time after start of exposure: ca. 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5ml/kg

VEHICLE
- Maize oil

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0, 3, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

Skin reactions were evaluated by the method of Draize et al (J. Pharamcol. Exp Ther. 82 (1944) 377-390)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No treatment related effects were observed. All animals gained weight during the 14-day observation period. Some animals showed a slight dip in body weight on postdosing day 3.

Gross pathology:

Effects on organs:
No gross abnormalities were observed.

Other findings:

Signs of toxicity (local):
Males: slight erythema.

Females: slight to moderate erythema, slight or moderate
encrustations and very slight or slight oedema during the
first week after exposure.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study, the LD50 value was determined to be >2000 mg/kg for the test substance