Reaction mass of 2-amino-2-methyl-1-propanol hydrochlorid (3207-12-3) and 2-amino-2-methyl-1-propanol (124-68-5)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 May 2018 - 26 June 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

1

Reference substance name:

(2-hydroxy-1,1-dimethylethyl)ammonium chloride

EC Number:

221-713-5

EC Name:

(2-hydroxy-1,1-dimethylethyl)ammonium chloride

Cas Number:

3207-12-3

Molecular formula:

C4H11NO.ClH

IUPAC Name:

1-hydroxy-2-methylpropan-2-aminium chloride

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Facility, Bioneeds India Private Limited, Devarahosahally, Sompura Hobli, Nelamangala Taluk, Bangalore Rural District, PIN - 562 111, Karnataka, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 160 - 180 g
- Housing: max. 3 animals per cage
- Diet: Altromin Maintenance diet for rats and mice 1324 manufactured by Altromin Spezialfutter GmbH & Co. KG, ad libitum
- Water: Deep bore-well water passed through Reverse osmosis unit, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 to 15 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: water is the recommended vehicle by the guideline

Doses:

300 mg/kg bw

No. of animals per sex per dose:

2 x 3 females in the first run (300 mg/kg bw/d)
2 x 3 females in the second run (2000 mg/kg bw/d)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) post dosing on Day 1 and at least once daily thereafter for clinical signs of toxicity throughout the experimental period. Individual animal body weight was recorded at receipt, on day 1 before test item administration and on day 8 and 15 during the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, histopathology

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at any of the dose levels tested.

Clinical signs:

other: In Step-I and Step-I confirmation, the animals were dosed with 300 mg/kg body weight. No clinical signs of toxicity and mortality were observed. In Step-II and Step-II confirmation, the animals were dosed with 2000 mg/kg body weight. No clinical signs of

Gross pathology:

No gross pathological changes were observed in any of the animals dosed at 300 and 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this OECD 423 compliant study, it is concluded that the LD50 value for the test item is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat.

Executive summary:

The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline No. 423. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight as there was no information available on the acute toxicity of the test item. A total of 12 females (3 females each for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item and all animals of Step II and Step II confirmation were administered with 2000 mg/kg body weight of the test item by oral route. All animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were sacrificed under carbon dioxide anaesthesia, subjected to necropsy and gross pathological examination. In Step-I and Step-I confirmation, the animals dosed with 300 mg/kg body weight did not reveal any clinical signs of toxicity and mortality. In Step-II and Step-II confirmation, the animals dosed with 2000 mg/kg body weight did not reveal any clinical signs of toxicity and mortality. No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 and 2000 mg/kg body weight. All the animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the animals dosed at 300 and 2000 mg/kg body weight.

Based on the results of this OECD 423 compliant study the LD50 value for the test item is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat.