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EC number: 629-661-9 | CAS number: 83834-59-7
- LD50 > 5000 mg/kg bw
- LD50 > 126.3 mg/kg bw
- LC50 > 511 mg/m³ air
- Sublethal doses: Ataxia and respiratory depression
- Lethal dose: Temporarily cramps
- None of the animals died late (after ten days of study)
It should be noted that 2-Ethylhexyl 4-methoxycinnamate (the active ingredient )was contained in a spray can, together with solvents and propellents in proportions listed above.
The reported concentrations represent in most instances the vapour concentrations of the volatile components, which were analysed using GC-FID. The resulting propane and butane concentrations were then used to calculate LC50 -values for the two samples, i.e. >41.8 mg/m³ (sample I) and >43.3 mg/m³ (sample II).
The volatility of the active ingredient, 2-Ethylhexyl 4-methoxycinnamate, is however low. This compound is predominantly present in the particle fraction.The particles were adsorbed to Florisil in the breathing zone of the test animals. HR 92/660 523 was then eluted from Florisil with ethanol and quantified by GC-FID, using a calibration curve of HR 92/660 523 (purity: 99.15 %). The concentration of the active ingredient was 497 and 524 mg/m³ in samples I and II, respectively (cf. report page 40). The mean concentration is therefore 511 mg/m³.
It should be noted that particle size distribution was influenced by the solvent composition. Particles with a Mass Median Aerodynimc Diameter (MMAD) of </= 3.0 µgm were considered to be respirable. Based on the results of the particle analysis, the dose of 2-Ethylhexyl 4-methoxycinnamate was 0.104 mg/L with sample 1, and 0.21 mg/L with sample 2.
MMAD ± geometric SD (µm)
8.29 ± 3.47
3.78 ± 2.36
Respirability (% = 3 µm)
21 % (measured)
40 % (measured)
100 % (extrapolated)
99 % (extrapolated)
In an acute inhalation toxicity study (Bayer AG, 1993), groups of young adult Wistar rats (male and female,5/sex) were exposed by inhalation route to HR 92/660 523 (2-Ethylhexyl 4-methoxycinnamate) contained in spray can at 2 and 5 %, respectively, along with considerable amounts of ethanol as solvent, and hydrocarbons as propellents. The rats were exposed for 4 hours to head only at a mean concentration of 0.511 mg 2-Ethylhexyl 4-methoxycinnamate /L. The animals then were observed for 14 days.
There were no findings in any test animal regarding mortality, clinical signs, changes in functional tests (reflexes and grip strength), or gross pathology except from a slightly reduced body weight gain in exposed animals, but without gaining a level of statistical significance. Therefore, the LC0 was 0.511 mg/L in male and female rats.
This study design is regarded to be suitable for testing the acute inhalation toxicity of low volatility compounds like 2-Ethylhexyl 4-methoxycinnamate. The study was conducted similar to OECD Test Guideline No. 403 and under GLP conditions. The acute LC0(4 h) was 0.511 mg/L in male and female Wistar rats.
A sunscreen cream containing an end concentration of 2.5 - 7.5 % ethylhexyl methoxycinnamate is tested for acute dermal toxicity on male and female rats (5 per sex). Weight varied from 200 - 250 gram, and the maximal applicable dose is set at 5 mL/kg (representing a dose of 126.3 mg/kg bw ethylhexyl methoxycinnnamate). This dose is applied to the skin, occluded by aluminium foil and held there for 24 hours. After exposure, rats were observed for 14 days.
The study found no symptoms or mortality in any rat after 24 hours following a single dose. Loss of bodyweight was seen in female rats in week one, but this restored in week two. Weight gain of male rats was comparable to the control. Terminal autopsy findings were normal.
It was concluded that the dermal LD50 to rats for a cream containing up to 7.5 % Ethylhexyl Methoxycinnamate is greater than 126.3 mg/kg bw, which is considered to be the maximum dosage.
In the key study (BASF SE, 1984, similar to current guideline studies, no GLP) for acute oral toxicity, no effects in rats at a dose of 5000 mg/kg were observed. This was supported by an acute oral toxicity study (Pellimont, 1968, no guideline, no GLP) in mice, in which a high single oral dose of 8000 mg/kg/day ethylhexyl methoxycinnamate caused no deaths and only slight effects (temporarily cramps). The dose of 5000 mg/kg bw was chosen as most critical value.
In the key study (Kynnoch et al, 1977, precursor of OECD 402, no GLP) for acute dermal toxicity, no effects were observed at a concentration of 126.3 mg/kg bw ethylhexyl methoxycinnamate (based on 2.5% formulation). The LD50 is therefore higher than this tested value. No supporting studies were available.
In the key study (Martins and Paulutin, 1993, OECD 403, GLP) for acute inhalation toxicity, no mortality at a concentration of 0.511 mg ethylhexyl methoxycinnamate/L air or 511 mg ethylhexyl methoxycinnamate/m³ air was observed. The LC50/LD50 is therefore higher than this tested value. No supporting studies were available.
No toxic effects (no mortality) were found in rats after oral, as well as dermal and inhalation exposure. The LD50 values were therefore established as greater than the highest doses tested. Based on these results, ethylhexyl methoxycinnamate cannot be classified as acute toxic according to the criteria for classification outlined in Annex I of 1272/2008/EC (no key parameters were established).
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