[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

A readacross with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride is proposed. The substance detailed in section 1 and the analogue material are both salts of 2-(2,4-diaminophenoxy)ethanol with similar physical and chemical properties.

Data source

Reference

Reference 1

Reference Type:

other: Published secondary source

Title:

Unnamed

Year:

2006

Report date:

2006

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

other: Single dose acute toxicity study

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

EC Number:

266-357-1

EC Name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

Cas Number:

66422-95-5

Molecular formula:

C8H12N2O2.2ClH

IUPAC Name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

Details on test material:

Test item : Imexine OAJ 2952
EC number : 266-357-1
Batch number : 0101297
Purity : 99.6%

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, France
- Age at study initiation: ~6 weeks old
- Weight at study initiation: 195+/-3g for males and 156+/-6g for females
- Fasting period before study: ~18 hours before dosing
- Housing: Polycarbonate cages (48cm x 27cm x 20cm)
- Diet (e.g. ad libitum): All animals had free access to A04C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): Drinking water filtered by FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): ~12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: On day 15 (1998-07-09) all surviving animals were killed by carbondioxide asphyxiation

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10w/v%
- Amount of vehicle (if gavage): <10 ml/kg
- Justification for choice of vehicle: solubility
- Lot/batch no. (if required): 0101297 (test item)
- Purity: 99.6% (test item)

Doses:

1000 mg/kg bw

No. of animals per sex per dose:

One group of 5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 30min, 1, 2, 4, 6hours, days 2-15 (clinical signs); days 1, 8, 15 (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination of main organs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Mortality:

A single dose of 1000 mg/kg bw induced death in 1/5 male and 3/5 female rats.

Clinical signs:

other: Hypoactivity or sedation and piloerection were noted in all animals on day 1. Lateral recumbency and tonic-clonic convulsions were also observed in two animals on day 1, one of these animals was found dead a few hours later. One male and two females were

Gross pathology:

No apparent abnormalities were observed at necropsy in all animals.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats. Based on the available data for 2-(2,4-diaminophenoxy)ethanol dihydrochloride the acute oral toxicity of 2-(2,4-diaminophenoxy)ethanol sulphate is calculated to be 1104 mg/kg bw.

Executive summary:

For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. The acute oral toxicity of the substance was assessed according to OECD 401 incompliance to GLP. Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw. Based on the available data for 2-(2,4-diaminophenoxy)ethanol dihydrochloride the acute oral toxicity of 2-(2,4-diaminophenoxy)ethanol sulphate is calculated to be 1104 mg/kg bw. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is classified as harmful if swallowed.