Phenol, dodecyl-, branched

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-09-20 until 1984-10-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to internationally accepted testing guideline, well doumented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

p-Isododecylphenol

IUPAC Name:

p-Isododecylphenol

Details on test material:

- Name of test material (as cited in study report): Isododecylphenol
- Molecular formula (if other than submission substance):
- Physical state: liquid
- Analytical purity: 97%
- Impurities (identity and concentrations): 3% Decylphenol
- Composition of test material, percentage of components: not mentioned
- Purity test date: not mentioned
- Lot/batch No.: not mentioned
- Production date of the lot/batch: 1984-03-22
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: average weight male = 136 g; female = 120 g
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
1.67 - 2.66 ml/kg bw

Doses:

1580, 1990, and 2510 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: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Preliminary study:

A preliminary test with a small number of animals was carried out from 1984-09-18 to 19984-10-02, to etablish the dose. No more details mentioned.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 200 mg/kg bw

Mortality:

1580 mg/kg bw: no animals died
1990 mg/kg bw: no male and two females died after 72 h
2510 mg/kg bw. five males and three females died after 96 h

Clinical signs:

other: The signs observed 30 minutes after administration were ruffled fur and later on a crouched posture, diarrhoea, diuresis, bloodstained mose, small deep-red eyes, retarded motion, slight to medium sedation and ataxia, and at the highest dose the animals fr

Gross pathology:

Post mortem dissection revealed severe hyperaemia of the gastro-intestinal tract.
Dissection of surviving animals at the end of the experiment revealed, in some animals, hyperaemia of the small intestinal mucosa as well as hypermaeia and swelling of the gastric mucosa. Furthermore, fusion of stomach with spleen, pancreas, left kidney and diaphragm was observed in one animal.

Any other information on results incl. tables

Table #: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
1580	0 / 5	0 / 5	0 / 10	-	5 / 5	5 / 5	10 / 10
1990	0 / 5	2 / 5	2 / 10	72	5 / 5	5 / 5	10 / 10
2510	5 / 5	3 / 5	10 / 10	96	5 / 5	5 / 5	10 / 10

 

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU