[No public or meaningful name is available]

Endpoint summary

Description of key information

A reliable oral acute toxicity study is available on 2 -moles Ethoxylated bisphenol A dimethacrylate, which is not harmful by oral route with an oral LD50 higher than 35 000 mg/kg bw.
A dermal acute toxicity study was performed; no mortality was observed at 2000 mg/kg in rats, therefore the dermal LD50 is higher than 2000 mg/kg.
There is no available study by inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-03-18, 1975-03-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test substance was administered undiluted in the highest tolerable amount of 30 ml/kg bw to groups of 10 males and 10 females.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute's colony
- Age at study initiation: no data
- Weight at study initiation: males 104-225g, females 79-194g
- Fasting period before study: forr 18 hours prior dosing
- Housing: in groups of five in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): stock diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C
- Humidity (%): no data
- Air changes (per hr): no details, "well-ventilated" room
- Photoperiod (hrs dark / hrs light): no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

no

Doses:

30 ml/kg (corresponding to 35 g/kg)

No. of animals per sex per dose:

10 males and 10 females per dose

Control animals:

no

Details on study design:

Animals were observed during 14 days for signs of intoxication.
Autopsies were carried out on the surviving animals at the end of the 14-days period.

Statistics:

no

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 35 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: No mortality observed

Mortality:

No death occurred during the observation period.

Clinical signs:

other: None of the treated animals showed any reaction upon treatment.

Gross pathology:

At the end of the 14-days period the survivors revealed no gross pathological changes.

Other findings:

Obviously both materials are of a very low acute oral toxicity. No difference in acute toxicity was observed between two samples.

Interpretation of results:

GHS criteria not met

Conclusions:

According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.

Executive summary:

Test substance was administered undiluted in the highest tolerable amount of 30 ml/kg bw (corresponding to 35 000 mg/kg bw) to groups of 10 males and 10 females. Animals were observed during 14 days for signs of intoxication. Autopsies were carried out on the surviving animals at the end of the 14-days period.

No death occurred during the observation period. None of the treated animals showed any reaction upon treatment. At the end of the 14-days period the survivors revealed no gross pathological changes. According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

35 000 mg/kg bw

Quality of whole database:

This oral acute study is considered to be reliable with a klimisch score of 2.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 October 2012 - 06 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011; including the most recent partial revisions.

Version / remarks:

2011

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 12 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Individual housing in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.

IN-LIFE DATES: From: 23 October 2012 - 06 November2012

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).

Frequency: Single dosage, on Day 1.

Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Dose volume: 1.79 mL/kg, calculated as dose level (g/kg) / specific gravity.

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Twice daily.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.

Statistics:

None.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

no

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal study in rats, the dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate was established to exceed 2000 mg/kg body weight. Based on these results, 2 moles ethoxylated bisphenol A dimethacrylate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and
mixtures (CLP), including all amendments.

Executive summary:

2-moles ethoxylated bisphenol A dimethacrylate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred and no clinical signs were noted. The mean body weight gain during the observation period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate in Wistar rats was established to exceed 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

2 000 mg/kg bw

Quality of whole database:

This dermal acute study is considered to be reliable with a klimisch score of 1.

Additional information

Acute toxicity : via oral route (TNO 1975)

2-moles ethoxylated bisphenol A dimethacrylate was administered undiluted in the highest tolerable amount of 30 ml/kg bw (corresponding to 35 000 mg/kg bw) to groups of 10 males and 10 females. Animals were observed during 14 days for signs of intoxication. Autopsies were carried out on the surviving animals at the end of the 14-days period.

No death occurred during the observation period. None of the treated animals showed any reaction upon treatment. At the end of the 14-days period the survivors revealed no gross pathological changes. According to these results, oral LD50 of test item is higher than 35 000 mg/kg bw in rats.

 

Acute toxicity : via dermal route (WIL 2013)

2-moles ethoxylated bisphenol A dimethacrylate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred and no clinical signs were noted. The mean body weight gain during the observation period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value of 2 moles ethoxylated bisphenol A dimethacrylate in Wistar rats was established to exceed 2000 mg/kg body weight.

 

Justification for classification or non-classification

Based on the available data, no classification for acute toxicity is required for 2 modes ethoxylated bisphenol A dimethacrylate according to the Regulation EC N°1272/2008.

Justification : The oral and dermal LD50 are higher than 2000 mg/kg bw.