9,9-bis-(methoxymethyl)fluorene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

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

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

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

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)

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.

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

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method A.4 (Vapour Pressure)

Version / remarks:

EC Directive 92/69 A.4 - Static method

GLP compliance:

yes

Type of method:

static method

Temp.:

30 °C

Vapour pressure:

53.3 Pa

Remarks on result:

other: First vapour pressure

Temp.:

110 °C

Vapour pressure:

3 866.3 Pa

Remarks on result:

other: Second vapour pressure

Temp.:

21 °C

Vapour pressure:

0 Pa

Remarks on result:

other: Estimated vapour pressure value.

Conclusions:

The vapour pressure of this substance was determined to be negligible at 21.0°C as expected for a solid material.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information