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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
reproductive toxicity, other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Scientific Opinion on the re-evaluation of propyl gallate (E 310) as a food additive
Author:
European Food Safety Authority (EFSA)
Year:
2014
Bibliographic source:
EFSA Journal 12(4), 3642
Reference Type:
publication
Title:
The toxicity of the antioxidants propyl-, octyl-, and dodecylgallate
Author:
Van Esch G.J.
Year:
1955
Bibliographic source:
Voeding 16, 683–686
Reference Type:
publication
Title:
Elementary raw fats containing phenolic antioxidants, an evaluation from the point of hygiene
Author:
Karplyuk I.A.
Year:
1960
Bibliographic source:
Voprosy Pitaniya 19(1), 67-72
Reference Type:
publication
Title:
Studies on the toxicity of propyl gallate and of antioxidant mixtures containing proply gallate
Author:
Orten J.M. et al.
Year:
1948
Bibliographic source:
Food Technology 2, 308-316

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Based on the presented data in the EFSA publication "Scientific Opinion on the re-evaluation of propyl gallate (E310) as a food additive" from 2014 it can be concluded that Propyl gallate does not warrant classification for reproductive toxicity.
Executive summary:

In the EFSA publication "Scientific Opinion on the re-evaluation of propyl gallate (E310) as a food additive", 2014 several reproductive toxicity studies conducted with Propyl gallate were presented.

For rats, the results from the study reported by van Esch, 1955 were summarized. In this study, rats were fed Propyl gallate in the diet at concentrations equivalent to doses of 18.2, 104 or 260 mg/kg bw/day for 2 successive generations. No effects on reproduction performance nor on indices of reproduction were reported, and at autopsy no abnormalities were observed in the organs or tissues of the rats.

In the CIR review, 2007 data from van Esch, 1955 was cited. It was reported that rats were fed Propyl gallate in the diet at concentrations equivalent to 31.5, 180 or 450 mg/kg bw/day for more than 3 months until a few litters had been produced. Propyl gallate was reported not to have produced any significant changes in growth or reproduction and no significant abnormalities were attributed to treatment at necropsy. At 31.5 mg/kg bw/day, organ weights and haematological values did not differ significantly from control.

At doses of 4 mg/kg bw/day in rats for 6 months followed by 8 mg propyl gallate per kg bw/day for a further 6 months, degenerative changes in the testes were observed (Karplyuk, 1960). This study was judged to be inadequately reported and thus not considered for the assessment.

For guinea pigs, the results from the study reported by Orten et al., 1948 were provided. Male and female guinea pigs (14 males and 6 females/group, 3 -4 weeks old) were dosed in the diet with 0 or 4.68 mg Propyl gallate/kg bw/day. After 12 months, the six females in each group were mated with males from the same group. Only one litter with three offspring was obtained from the six control females while three litters of three offsprings were obtained from the six dosed females. There was no effect on gross appearance or rate of growth and no gross abnormalities were found at autopsy. Histological examination of liver, kidney, spleen, testes ovaries, adrenals, heart and lungs did not disclose any pathological effects. It was not specified if mothers and/or offspring were examined. There was no compound effect on the growth of one litter of the dosed females when compared to one litter of the control animals.

For pigs, the results provided by van Esch, 1955 were reported in the EFSA review publication. Pigs fed with Propyl gallate in the diet with concentrations of 0.0035, 0.2 or 200 mg/kg diet for more than three months until a few litters had been produced. Propyl gallate was reported not to have produced significant changes in growth or reproduction and no significant abnormalities were attributed to treatment at necropsy. At 14 mg/kg bw/day 0.0035 diet, organ weights and haematological values did not differ significantly from control.