2-Propanol, 1,1'-(tridecylimino)bis-

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:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Batch No.: Batch 704/tank 328
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr . K . Thomae GmbH, 7950 Biberach, Germany
- Weight at study initiation: (200 g - 300 g ; ± 20% of the mean weight)
- Housing: Single housing in Stainless steel wire mesh cages, type DK-III (Becker & Co, Castrop- Rauxel, Germany) .
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Clipping of the fur: at least 15 hours before the beginning of the study
- Area of exposure: dorsal and dorsolateral parts of the trunk; 50 cm2
- Type of wrap if used: the bandage consist of four layers absorbent gauze
REMOVAL OF TEST SUBSTANCE
- Washing: warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of administration, thereafter at least once each workday for the individual animals
- Freuqency of weighing: shortly before the study and at the last day
- Necropsy of survivors performed: yes
- Other examinations performed: Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1),
weekly thereafter and at the end of the study (last day of the observation period)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed

Clinical signs:

No abnormalities

Body weight:

body weight gain

Gross pathology:

No pathological findings

Other findings:

Local effects (see table 1):
In the male animals moderate to severe erythema and in single cases additionally slight edema, incrustation and scaling were seen. 14 days after application in all male animals signs of reversibility were observed.
In the female animals well-defined erythema, scaling and in some cases slight edema were seen. Erythema could still be observed 14 days after application.

Any other information on results incl. tables

Table 1: Number of treated male and female animals with Edema / erythema and duration of adverse effects.

	males		females
	Number of animals	Reversibility	Number of animals	Reversibility
moderate to severe erythema	4	D1
well-defined erythema	5	D1-D7	5	D1-D14
very slight erythema	2	D7-D14	3	D14
slight edema	3	D1	2	D1
very slight edema	1	D1	3	D1
scaling	5	D7-D14	5	D7-D14
incrustation	4	D7-D14	1	D7