Registration Dossier
Registration Dossier
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EC number: 235-747-3 | CAS number: 12650-88-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NA
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
See the considerations below.
Short description of key information:
Lysozyme is expected to be non-toxic for reproduction.
Effects on developmental toxicity
Description of key information
Lysozyme is expected to be non-toxic for reproduction.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Both proteolytic and non-proteolytic enzymes have been investigated for their teratogenic and reproductive toxicity potential. Several of these studies have been published in peer reviewed articles [1 -4].
Furthermore, enzymes have been used for decades to treat pancreatic insufficiency in both children and adults without any evidence of reproductive toxicity [5]. Toxicokinetic data together with the enzymatic structure and the weight of evidence from animal studies and human exposure provide no evidence for reproductive toxicity of enzymes. Investigations of enzymes in vitro screening systems for endocrine disrupters cannot be expected to provide any new knowledge due to the nature of enzymes, especially since the majority of screening studies deals with receptor mediated mechanism. It is most unlikely that new animal studies will provide any new knowledge, because the results and conclusions of numerous animal studies, investigating effects on fertility and teratogenicity and the repeated dose oral toxicity studies in vivo have not identified any adverse effects related to reproduction. Thus, reproductive toxicity studies are considered scientifically and ethically unjustified.
In the Luce and Pellegrini handbook [6] is reported that administration of Lysozyme during the organogenesis period in mice and rabbits does not have a teratogenic action: the foetus were normal in weight, number and implantation sites and the same applied to resorptions or skeletal structure.
Taking into account the preliminary considerations and the literature data available, Lysozyme is not expected to be toxic for reproduction and developmental.
Reference
[1] Greenough RJ, Everett DJ (1991) Safety evaluation of alkaline cellulase. Food and Chemical Toxicology 29: 781-785.
[2] Deboer, A.S., Marshall, R., Broadmeadow, A., and Hazelden, K. (1993) Toxicological Evaluation of Acetolactate Decarboxylase. Journal of Food Protection 56, 510-517
[3] Hjortkjaer, R.K., Bille-Hansen, V., Hazelden, K.P., McConville, M., McGregor, D.B., Cuthbert, J.A., Greenough, R.J., Chapman, E., Gardner, J.R., and Ashby, R. (1986) Safety evaluation of Celluclast, an acid cellulase derived from Trichoderma reesei. Food Chem.Toxicol 24, 55-63
[4] Stavnsbjerg, M., Hjortkjaer, R.K., Billehansen, V., Jensen, B.F., Greenough, R.J., McConville, M., Holmstroem, M., and Hazelden, K.P. (1986) Toxicological Safety Evaluation of A Bacillus-Acidopullulyticus Pullulanase. Journal of Food Protection 49, 146-153
[5] Barak, A., Dulitzki,M., Efrati, O., Augarten, A., Szeinberg, A., Reichert, N., Modan, D., Weiss, B., Miller, M., Katzanelson, D., and Yahav, Y. (2005) Pregnancies and outcome in women with cystic fibrosis. Israel Medical Association journal: IMAJ 7, 95-98
[6] Enzymes REACH Consortium. ERC Data waiving argumentation for technical enzymes. 2010
Toxicity to reproduction: other studies
Additional information
NA
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Lysozyme is not classified for toxicity for reproduction.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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