Fatty acids, C16 and C18-unsatd., polymers with bisphenol A, Bu glycidyl ether, epichlorohydrin and triethylenetetramine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 September 2012 to 22 March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Fully GLP compliant and in accordance with current test guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Viscous semi-solid

Details on test material:

Name: MonoFA_TETA_PAA_BADGE_BGE_Adduct
CAS number: 105839-18-7
Batch number: WA521
Purity: 100%
Expiry date: 28 Feb 2014
Receipt date: 03 Sep 2012
Storage: stored in a sealed container, at room temperature in the dark.

Test animals

Species:

rat

Strain:

other: HsdHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: The weight variation did not exceed ±20% of the mean weight.
- Fasting period before study: From the evening of the day prior to dosing (Day -1) until approximately 3 hours after dosing.
- Housing: Housed in groups of up to five during the acclimatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day –1), the rats were housed in groups of three in similar cages.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 28 to 30 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): The animal rooms were designed to permit 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.

IN-LIFE DATES: From: 15 October 2012 To: 01 November 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: PEG 400 as this was found to produce a suitable formulation at the highest concentration.
- Lot/batch no. (if required): Not reported
- Purity: Not reported

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

Each rat was dosed twice on Day 1 (with an interval of one hour between administrations) by passing the tip of a catheter along the oesophagus and instilling the test article into the gastric lumen.

No. of animals per sex per dose:

3 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Clinical signs were recorded immediately after first administration and 15 and 30 minutes after first administration. Clinical signs were then recorded immediately after the second administration, at approximately 15 and 30 minutes after the second, hourly between 1 and 4 hours after the second administration (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period.
Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No clinical signs were seen.

Gross pathology:

No abnormalities were noted at necropsy except for red thymus in one animal and gaseous distension of the colon in one other animal.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute median lethal oral dose level of the test article, MonoFA_TETA_PAA_BADGE_BGE_Adduct, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

This study was conducted to assess the acute toxicity of the test article, MonoFA_TETA_PAA_BADGE_BGE_Adduct following oral administration to rats.

Groups of three female fasted rats were given the test article on Day 1 by oral gavage at a dose level of 2000 mg/kg. The test article was dispersed in PEG 400 at a concentration of 100 mg/mL and administered at a dose volume of 10 mL/kg on two occasions approximately one hour apart. All animals were killed on Day 15 and subsequently underwent a full necropsy.

There were no deaths and no clinical signs were seen.

All rats achieved body weight gains over the study period.

No abnormalities were noted at necropsy except for red thymus in one animal and gaseous distension of the colon in one other animal.

The acute median lethal oral dose level of the test article, MonoFA_TETA_PAA_BADGE_BGE_Adduct, was found to exceed 2000 mg/kg.

The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).