Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 05 August 1997 to 10 October 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to EU / OECD guidelines and non- GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda

EC Number:

939-368-0

Cas Number:

1322-93-6

Molecular formula:

Not applicable (a generic molecular formula can not be provided for this specific UVCB substance)

IUPAC Name:

Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

See confidential details on test material section

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle. France.
- Age at study initiation: 6 weeks old
- Weight at study initiation: 177-206 g for the males, 162-186 g for the females
- Fasting period before study: Animals are fasted the day before. They are divided into 3 groups of 10 (five of each sex).
- Housing: The animals were housed in groups of 5 animals of the same sex in polypropylene cages (310x465x190).
- Food consumption (e.g. ad libitum): ad libitum. Pelleted feed UAR A04-10 (91360 - EPINAY SUR ORGE, FRANCE)
- Water consumption (e.g. ad libitum): ad libitum
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

In-life dates: From 05 to 28 August 1997

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
The vehicle used was distilled water (Meram lot 62421)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg


DOSAGE PREPARATION:
The test substance is used diluted in distilled water. It is maintained under magnetic stirring for the duration of treatment.

Doses:

200, 600 and 1800 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed frequently after administration of the test substance and at least once a day for clinical signs and at least twice a day for mortality.
- Frequency of weighing: Animals were weighed just before administration of the test substance and then on days 4, 8 and 15.
- Necropsy of survivors performed: yes on day 15
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities)

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 600 - < 1 800 mg/kg bw

Based on:

test mat.

Mortality:

At 200 and 600 mg/kg, no deaths occured during the observation period.
At 1800 mg/kg, one female died after 5 h, 2 males and 3 females died on day 2.

Clinical signs:

other: No clinical signs were observed during the study in animals treated with 200 and 600 mg/kg. Piloerection, decreased motor activity, hypertension and loss of grip were noted in animals treated with 1800 mg/kg at least until the 6th hour of observation. Dur

Gross pathology:

The macroscopic examination of the main organs of the animals death during the test or sacrified at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the oral LD50 of the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda was between 600 and 1800 mg/kg in rats.

Executive summary:

The substance reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda has been tested for acute oral toxicity in Sprague Dawley rats, according to O.E.C.D. guideline Nb.401. The test article (76% active), diluted in distilled water, was administered as a single dose of 200, 600 and 1800 mg/kg bw to groups of 5 males and 5 females, at a dosing volume of 5 ml/kg. Following treatment, mortality, clinical signs and body weight were recorded for a two-week observation period. On day 15, the animals were euthanatized and necropsied.

 

At 200 and 600 mg/kg, no deaths occured during the observation period. At 1800 mg/kg, one female died after 5 h, 2 males and 3 females died on day 2. 

No clinical signs were observed during the study in animals treated with 200 and 600 mg/kg. Piloerection, decreased motor activity, hypertension and loss of grip were noted in animals treated with 1800 mg/kg at least until the 6th hour of observation. During the daily examinations performed during the observation period day 2 to day 15, no impairment of general condition and behavior of surviving animals were noted.

The body weight gain of the animals was normal in animals treated with 200 and 600 mg/kg. The body weight gain of the surviving males treated with 1800 mg/kg on day 15 was slightly lower (-14%) than other doses, but their weight change was however satisfactory. The surviving female treated with 1800 mg/kg presented a slight weight loss at day 4. This weight drop was offset later, his weight gain appeared normal and satisfactory at the end of the observation.

The macroscopic examination of the main organs of the animals dead during the test or sacrified at the end of the study revealed no apparent abnormalities.

 

As the acute oral LD50 was found between 600 and 1800 mg/kg (456 -1368 mg/kg as active) under the conditions of the test, reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is classified as Acute tox. 4 (H302) according to the Regulation (EC) 1272/2008 (CLP) and as harmful Xn, R22 according to the Directive 67/548/CEE.