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Description of key information

The acute oral median lethal dose (LD50) of the test substance registered were determined in an OECD 401 acute toxicity test. A supporting study performed as ALD (Approximate lethal Dose) study is also available.

The acute inhalation toxicity of the test substance registered were determined in an Approximate Lethal Concentration (ALC) study, where two groups of 6 male rats were exposed nose-only, a single 4 -hour period to the test substance in air.

According to REACH 1972/2006, Annex VIII, column 2, 8.5, in addition to oral route, for substance other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. Thus, the acute dermal toxicity study can be waived since the data of acute toxicity by oral and inhalation route is available and sufficient for assessment of acute toxicity of the registration substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliability of 2 . No GLP information. Study is well documented.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Reliability of 2 (reliable with restriction). The study is well documented. The MMAD for the high dose tested achieved only particle sizes of 6.8 µm, which is greater than the targeted MMADs of 1 to 4 µm to allow maximum lung exposure. Under the conditions of this study, the approximate lethal concentration (ALC) for the test item H-25777 is greater than 1.8 mg/L. Several attempts were made to produce smaller, more respirable aerosol size; however, it appeared that this could not be accomplished at these high concentrations due to the condensation aerosol forming large particle agglomerates. The used concentrations seems to be the highest concentration technical achievable. Histopathologically examination was only performed in the low dose group tested. Although the histopathology is not part of such kind of acute toxicity studies an examination of the high dose group would have been valuable.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

To assess the acute toxicity of the Perfluoroalkylethylacrylate when administered by oral gavage to rats, followed by an observation period of 14 days was performed in an OECD 401 study. A single dose of 2000 mg/kg bw was administered. No deaths ocurred during the entire observation period. The acute median lethal dose (LD50) of the test substance registered to the Wistar rat was found to be greater than 2000 mg/kg body weight. A supporting study performed as ALD (Approximarte Lethal Dose) study is also available for the Perfluoroalkylethylacrylate. Doses applied to one male rat each were 670, 2300, 5000, 7500 and 11,000 mg/kg bw. The ALD was determind to be greater 11,000 mg/kg bw in male rats. These results from the two acute oral studies with the mixed Perfluoralkylethylacrylate are in line with the read across substance n:2 FTOH mixture which was tested in an OECD 401 test for acute oral toxicity. Five rats/sex/dose were tested with 4000 and 5000mg/kg bw of the test substance disolved in strach slime 2%. 2/5 male and 1/5 females died within the 5000 mg/kg bw group. Within the 4000 mg/kg bw dose 1/5 males an 0/5 females died. Under the conditions of this test the LD50 oral rat of the test substance is considered to be greater than 2000 mg/kg bw.

Inhalation:

One study is available for the assessment of the acute toxicity of the test substance registered via inhalation. The acute inhalation toxicity were determined in an Approximate Lethal Concentration (ALC) study, where two groups of 6 male rats each were exposed nose-only, a single 4 -hour period to the test substance in air. Rats were exposed to atmospheres of the test substance in air at concentrations of 0.10 or 1.8 mg/L. The mass median aerodynamic diameters (MMADs) for the aerosol tested were 5.8 and 6.8 µm, respectively. No rats died following exposure to the test substance. Under the conditions of this inhalation study, the approximate lethal concentration (ALC) for the test item H-25777 is greater than 1.8 mg/L. However, the mass median aerodynamic diameter (MMAD) of the tested aerosol at this concentration was 6.8 µm. Targeted MMADs in inhalation studies are from 1 - 4 µm to allow maximum lung exposure. Several attempts were made to produce smaller, more respirable aerosol size; however, it appeared that this could not be accomplished at these high concentrations due to the condensation aerosol forming large particle agglomerates. The used concentrations seems to be the highest concentration technical achievable.

Dermal:

According to REACH 1972/2006, Annex VIII, column 2, 8.5, in addition to oral route, for substance other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. Thus, the acute dermal toxicity study can be waived since the data of acute toxicity by oral and inhalation route is available and sufficient for assessment of acute toxicity of the registration substance.

With regard to evaluate the hazard by dermal route the low toxicity of the registration substance is taken into account. The registration substance has low acute oral toxicity with an LD 50 oral, rat of ≥ 2000 mg/kg body weight and an Approximate Lethal Dose (ALD oral) of greater than 11,000 mg/kg body weight. The registration substance was not a skin or eye irritant and did not demonstrate skin sensitizing potential in a local lymph node assay.A substance after dermal application becomes only systemic available when first the skin as natural barrier is passed. As there are no data on acute dermal toxicity with the target substance available the dermal permeability of substances can be assessed on base of the molecular weight and the physic-chemical data, e.g. Log Pow. The molecular weight range of the test substance is between 418 and 818 andindicates therefore only limited dermal absorption potential.Likewisethe log Pow value of > 4 for the main constituent of the mixed FTAC also indicates low penetration through the skin (seeECHA Guidance for the implementation of REACH, Chapter R.7c, Nov. 2012 (version 1.1) andSANCO/222/2000 rev.7, 19 March 2004, Guidance Document on Dermal Absorption).Based on REACH guidance when the molecular weight is greater 500 and the log Pow smaller than -1 or above 4, about 10 % dermal penetration is proposed by default. However, even when significant dermal absorption would appear the systemic necessary doses to result in toxic effects would not be achieved.It is concluded that dermal penetration of the registration substance is negligible.Therefore, hazard by dermal penetration is expected to be low.

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS (Global Harmonized System for classification, labeling and packaging) Annex 1, the test substance has not to be classified.