9,9-bis-(methoxymethyl)fluorene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

March 22, 1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Dated 31 July 1992

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class 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

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: Charles River Wiga, Germany
Age: 5-6 weeks old upon arrival
identification: earmarked
Caging: five animals per cage (stainless stell cages, fitted with wire-screen floor and front)
Acclimatization: 9 or 13 days
Lighting: 12 hours light/dark cycle
Temperature: 22 +/- 3C
Ventilation: ca. 10 air changes/hr
Diet: standard chow ad libitum
Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

Animals were dosed with a dosing volume of 10 ml/kg bw of a 200 mg/ml suspension of test material in maize oil to obtain the 2000 mg/kg dose level. The exact amount of the test substance to be dosed was calculated for each animal and administered by means of a syringe, by oral gavage. Animals fasted overnight prior to dosing and 4 hours after.

Doses:

2000 mg/kg limit dose

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Animals were observed for mortality 14 days post exposure.
Body weights of each animal were recorded immediately before dosing on day 0 and in the surviving animals on days 3, 7 and 14 of the study.
Animals were sacrificed on day 14 with CO2 and subjected to gross pathology.

Results and discussion

Preliminary study:

No mortality observed in 2 males.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female was found dead on day 3

Clinical signs:

other: blepharospasm in two males was observed prior to death, the female showed sluggishness, blepharospasm, dyspnoea and coma

Gross pathology:

No treatment related gross alterations was observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since only one animal died during the 14 -day observation period, the oral LD50 of the test material is considered to exceed 2000 mg/kg body weight, in both male and female rats.