4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Dec - 31 Dec 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Restriction: purity of test substance not specified

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 12. May, 1981

Deviations:

yes

Remarks:

purity of test substance not given

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)

EC Number:

407-560-9

EC Name:

4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)

Cas Number:

107934-68-9

Molecular formula:

C25H18Cl2N2

IUPAC Name:

4-[9-(4-amino-3-chlorophenyl)-9H-fluoren-9-yl]-2-chloroaniline

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI, USA
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 240 - 299 g
- Fasting period before study: 17 to 20 hours (over night)
- Housing: separated by sex in groups of 5 in screen-bottom stainless steel cages (heavy gauge)
- Diet: Purina Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 21 - 31
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Dec To 31 Dec 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: vehicle was chosen due to good solubility of test substance in this vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

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: Each animal was observed for clinical signs and mortality at 1, 2.5 and 4 hours following administration, and daily thereafter for 14 days, once daily for clinical signs and twice daily for mortality, weighing was done just before dosing, on day 7 and at study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Average body weights were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed during the study period.

Clinical signs:

other: 1 male animal had diarrhea 4 hours after administration. 2 male animals had miosis starting at 2.5 hours following administration until day 1 and day 2, respectively. Some female animals showed miosis (1, 2.5 and 4 hours after administration and on day 1)

Gross pathology:

One female animal had multiple red pinpoint foci in the right salivary gland and diffusely dark red submandibular bilateral lymph nodes. A second female had an enlarged pelvis in the right kidney. The findings in the two female rats were considered to be incidental and unrelated to exposure. All other animals were without visible lesions.

Any other information on results incl. tables

Table 1: Clinical Signs (Number of animals affected)

	Hours			Days
	1.0	2.5	4.0	1	...	14
Males (5.0 g/kg)
Appeared Normal	5	3	2	4	...	5
Diarrhea	0	0	1	0	...	0
Miosis	0	2	2	1	...	0
Females (5.0 g/kg)
Appeared Normal	2	0	0	4	...	5
Miosis	2	3	3	1	...	0
Diarrhea	2	3	4	0	...	0
Hypoactivity	0	1	2	0	...	0
Lacrimation	0	3	3	0	...	0
Hypersensitivity to touch	0	0	1	0	...	0

Table 2: Average body weights (g)

	Dose Level	Average Body Weights (g)
	(g/kg)	Initial	Day7	Terminal
Male	5.0	280	344	367
Female	5.0	253	279	288

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined to be > 5000 mg/kg for male and female rats.

Executive summary:

The acute oral toxicity of the test substance to rats was investigated according to OECD TG 401 and following GLP principles. A limit test using a dose of 5000 mg/kg was conducted.

No mortality was observed in males and females.

The oral LD50 value of the test substance was established to be > 5000 mg/kg body weight.