reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 423, GLP 
Acute dermal toxicity: study scientifically not justified
Acute inhalation toxicity: study not necessary due to exposure considerations

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:

2010-06-08 - 2010-09-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six female Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatization period of at least five days. At the beginning of the study, the animals of the treated group weighed between 187 and 202 g and were 8 weeks old.
Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively.

The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water (tap-water from public distribution system) and foodstuff (M20-SDS) were supplied freely. Food was removed on D-l and then redistributed 4 hours after the test item administration. Microbiological and chemical analyses of the water were carried out once every six months by IPL, Santé, Environnement Durables - Atlantique.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals of the treated group received an effective dose of 2000 mg/kg body of the test item:
The test item was administered by gavage under a volume of 1.70 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density), using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2 g/kg, according to the calculated density

No. of animals per sex per dose:

6 female rats

Control animals:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

No clinical signs related to the administration of the test item were observed.

Body weight:

The body weight evolution of the animals remained normal throughout the study.

Other findings:

The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

In conclusion, the LD50 of the test item Epoxy half acrylate is higher than 2000 mg/kg body weight by oral route in the rat.

Executive summary:

The test item Epoxy half acrylate was administered to a group of 6 female Sprague Dawiey rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 423 dated December 17th, 2001 and the test method B.ltris of the Council regulation No 440/2008. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes. In conclusion, the LD50 of Epoxy half acrylate is higher than 2000 mg/kg body weight by oral route in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

In an acute oral toxicity study according to OECD guideline 423 (17 December 2001) and EU method B.1 tris (30 May 2008), 6 fasted female Sprague Dawley rats were given a single oral dose of Epoxy half acrylate at a limit dose of 2000 mg/kg bw and observed for 14 days.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes. In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.

 

Acute inhalation toxicity

Given that inhalation is not a relevant route of exposure, testing by the inhalation route is not necessary according to REACH Regulation Annex VIII 8.5.2 Column 2. Inhalation is not a relevant route of exposure to Epoxy half acrylate. This applies to both workers and the general population and is due to the physicochemical properties of the substance and the nature of the products where it is used. Generation of aerosols is not to be expected. Inhalation exposure by vapour does not need not to be considered due to the substance’s very low vapour pressure of < 1E-05 at 25°C.  

The generation of aerosols is excluded by technical means. The substance is not used in spray applications. Results of laboratory animal studies show a low acute toxicity after oral exposure. Therefore the acute intrinsic toxic activity Epoxy half acrylate is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.

 

Acute dermal toxicity

Testing of acute dermal toxicity of Epoxy half acrylate is scientifically not justified according to REACH Regulation Annex XI 1.

Results of laboratory animal studies show a low acute toxicity after oral exposure; LD50 for rats was > 2000 mg/kg bw. Therefore the acute intrinsic toxic activity Epoxy half acrylate is considered to be low. Although dermal penetration can be expected based on the skin irritating and sensitizing properties of the substance, dermal absorption is unlikely to be higher than oral absorption. The occurrence of acute systemic toxicity relevant to humans after dermal exposure is unlikely and therefore the conduct of an acute dermal toxicity study is unjustified. The dermal LD50 can be expected to be > 2000 mg/kg bw based on the considerations above.

Support is given by retrospective data analyses undertaken by Creton et al. (2010) and Seidle et al. (2010) to ascertain the value of regulatory requirements prescribing multiroute testing for acute systemic toxicity. These analyses have examined the concordance among regulatory classifications for acute oral, dermal, and/ or inhalation toxicity for ~500 agrochemical and biocidal active substances and nearly 2000 industrial chemicals. The findings from these two independent reviews have revealed that acute dermal studies of pure substances do not add value above and beyond oral data for hazard classification of pesticides, biocides, or chemicals. 

There are no data gaps for the endpoint acute toxicity. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

References

Seidle T. et al.: Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing, TOXICOLOGICAL SCIENCES 116(2), 382–396 (2010).

Creton S. et al.: Acute toxicity testing of chemicals—Opportunities to avoid redundant testing and use alternative approaches, Critical Reviews in Toxicology, 2010; 40(1): 50–83

Justification for selection of acute toxicity – oral endpoint
OECD guideline study, no deviations, RL1, GLP

Justification for classification or non-classification

Based on the available data, Epoxy half acrylate does not need to be classified for acute toxicity according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.