Ammonium 2-ethylhexyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

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

Constituent 1

Reference substance name:

Ammonium 2-ethylhexyl sulphate

EC Number:

274-625-4

EC Name:

Ammonium 2-ethylhexyl sulphate

Cas Number:

70495-37-3

Molecular formula:

C8H18O4S.H3N

IUPAC Name:

ammonium 2-ethylhexyl sulfate

Test material form:

cream / paste

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house bred
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 165.26 to 173.82 g
- Housing: Three animals were housed in standard polypropylene cage (Size: L 430 x B 285 x H 150 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
- Diet: ad libitum (altromin Maintenance diet for rats and mice 1324 manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water: ad libitum
- Acclimation period: Healthy young adult animals used for Step-I, Step-I confirmation, Step-II and Step-II confirmation were acclimatized for five, six, nine and eleven days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt and on 5th day of acclimatization.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 23.4
- Humidity (%): 45 to 65
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle: 10 mL
- Justification for choice of vehicle: Distilled water is universally accepted and routinely used vehicle in oral toxicity studies.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 female animals per step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 and body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No gross pathological changes were observed in any of the animals at 300 mg/kg 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 study the LD50 of the test item is >2000 mg/kg bw when administered as a single dose by oral gavage to female Sprague Dawley rats according to OECD 423.

Executive summary:

The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline 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 since the LD50 for test item is not available. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I and  Step-I confirmation were administered with 300 mg/kg body weight of the test item. Step II and Step-II confirmation were administered with 2000 mg/kg body weight of the test item through oral route. All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 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 humanely sacrificed under carbon dioxide asphyxiation, subjected to necropsy and gross pathological examination. No clinical signs of toxicity or mortality were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight. No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the animals at 300 mg/kg and 2000 mg/kg body weight.

Based on the findings of this study the acute oral LD50 of the test item is > 2000 mg/kg bw.