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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 Dec - 17 Dec 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Also in accordance with GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1984

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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:

Crj: CD(SD)

Remarks:

Crl. (CD) SD BR VAF plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Kent, England
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 205 - 243 g
- Housing: individually in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Biosure, LAD 1), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 46
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 3 Dec To: 17 Dec 1990

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorso-lumbar region
- % coverage: 10% of total body surface
- Type of wrap if used: gauze which was held in place by an impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: in warm water (30-40°C) and blotting dry with absorbent paper
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.0 mL/kg bw
- Concentration (if solution): 66.7% (w/v) in distilled water

Duration of exposure:

24 hours

Doses:

2000 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: animals were observed twice daily and weighing was carried out on day 1, 8 and 15 (day1 = day of dosing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation (treated areas of skin were observed daily for signs of irritation and assessed according to the Draize scoring system)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed during the study period.

Clinical signs:

other: No clinical sigsn of systemic effects were seen.

Gross pathology:

No abnormalitites were found at terminal necropsy.

Other findings:

- Other observations: No dermal reactions at the site of application were observed.

Any other information on results incl. tables

Table 1: Body weights

Sex	Dose	Animal number	Bodyweight in g (individual gain weekly) at
	(mg/kg)		Day1	Day8	Day15
Male	2000	1	243	320 (77)	384 (64)
		2	206	269 (63)	333 (64)
		3	232	310 (78)	378 (68)
		4	234	317 (83)	387 (70)
		5	231	306 (75)	377 (71)
	Mean		229	304	372
Female	2000	6	214	238 (24)	247 (9)
		7	225	259 (34)	276 (17)
		8	205	209 (4)	225 (16)
		9	217	233 (16)	260 (27)
		10	205	221 (16)	238 (17)
	Mean		213	232	249

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was determined to be > 2000 mg/kg.

Executive summary:

The acute dermal toxicity of the test substance to rats was investigated according to EEC B.3 and following GLP principles. A limit test using a dose of 2000 mg/kg was conducted.

No mortality was observed in males and females.

The dermal LD50 value of the test substance was established to be > 2000 mg/kg body weight.