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EC number: 225-714-1 | CAS number: 5026-62-0
Skin irritation (OECD 439): irritatingEye irritation (Code of Federal Regulations, Title 16, Section 1500.42): corrosive
mean corrected OD550of the duplicates
mean corrected OD550of 3 replicate tissues
mean SD OD550
tissue viability [%]
SD tissue viability [%]***
CV [% viability]
mean tissue viability [%]
* Corrected mean OD550 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the three positive control tissues is ≤ 20%
*** standard deviation (SD) obtained from the three concurrently tested tissues is < 18%
Table 1. Results of eye irritation study.
After the 8 d-observation period, the effects on cornea and the swelling of conjunctivae were not fully reversible in 2 animals and the effects on iris and the redness of the conjunctivae were not fully reversible in 3 animals.
Three studies are available addressing skin irritation and corrosion.
In a in vitro study, sodium methylparaben was investigated in a reconstructed human epidermis model (EpiDerm™) for skin corrosion according to OECD 431 and GLP (Lehmeier, 2012a). The tissues were exposed with 25 mg of the test substance in distilled water for 3 and 60 min.
Afterwards, the tissues were stained with MTT solution for 3 h. The estimation of tissue viability based on the reduction of MTT to a blue formazan product. A test substance has to be classified as skin corrosive if the mean tissue viability after 3 min is < 50% and after 60 min is < 15% relative to the respective mean negative control value. Tissue treatment with the test substance for 3 or 60 min resulted in mean tissue viabilities of 59% and 26%, respectively. The positive control substance (8 N KOH) led to tissue viabilities of 27% and 23% after 3 and 60 min incubation time, respectively.
Under the test conditions, the test substance was not considered to be skin corrosive.
In a second in vitro study, sodium methylparaben was investigated in a reconstructed human epidermis model (EpiDerm™) for skin irritation according to OECD 439 and GLP (Lehmeier, 2012b). The tissues were exposed with 25 mg of the test substance in phosphate buffered saline for 60 min. After a post-treatment period of 42 h, the tissues were stained with MTT solution for 3 h. The estimation of tissue viability based on the reduction of MTT to a blue formazan product.
Under the test conditions, the test substance was irritating to the skin (Category 2).
In the third study, the skin irritating properties of sodium methylparaben were tested in an in vivo study according to the Code of Federal Regulations, Title 16, Section 1500.41 (Schreiber, 1981a). An amount of 500 mg sodium methylparaben moistened with water was applied on the clipped and abraded skin of 6 New Zealand White rabbits and covered with an occlusive dressing for 24 h. The reading time points for erythema and edema formation were at 24 and 72 h after removal of the test substance. At the 24 h reading time point, erythema formation was observed in all animals (scores 1 or 2) and edema formation was observed in 3/6 animals (scores 1 or 3). After 72 h, erythema formation was observed in 5/6 animals (scores 1 or 2) and edema formation was observed in 3/6 animals (score 1). The effects were fully reversible in all animals within the 8 d observation period.
In summary, the available in vitro data show that the test substance was not corrosive but irritating to the skin. The in vivo study resulted in slight erythema and edema formation which was reversible within 8 days. However, since the in vitro studies are more reliable than the in vivo study, the test substance meets the criteria for classification as skin irritant (Category 2).
The eye irritating potential of sodium methylparaben was investigated in a study performed by Schreiber (1981b) according to the Code of Federal Regulations, Title 16, Section 1500.42. 0.1 mL of the unchanged test substance was instilled in one eye of each of 6 male New Zealand White rabbits without washing afterwards. The second eye of each animal was left untreated and served as control. The grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed 24, 48 and 72 h and 8 d after instillation of the test substance.
At 24 h post-application, swelling (score 1-3) and redness (score 2-3) of the conjunctivae were observed in all animals. The effects on conjunctivae persisted during the 48 and 72 h reading time point in all animals. After 8 d, the conjunctivae redness had fully reversed in 3/6 animals and the swelling of conjunctivae had fully reversed in 4/6 animals. Redness of the conjunctivae (score 1-2) was still noted in 3/6 rabbits and 2/6 rabbits still showed conjunctivae swelling (score 1). At 24 h post-application, effects on the iris (score 1) were observed in 5/6 rabbits. At the 48 h reading time point, the iris irritation (score 1) was noted in all animals. After 72 h, the effect persisted in 4/6 animals and reversed in 2/6 animals. After 8 d, the iris irritation had resolved in 3/6 animals. In all other rabbits the iris irritation still persisted. Corneal opacity (score 1-2) was noted in all rabbits after 24 h. The observation reversed in 2/6 animals within 48 h and in 2/6 other animals within 72 h. After 8 d, corneal opacity (score 1) was still noted in 2/6 animals.
Under the test conditions, the test substance was corrosive to the eyes (Category 1).
The available data on skin irritation and eye irritation of the test substance meet the criteria for classification as Skin Irritant (H315) and Irreversible effects on the eye (H318) according to Regulation (EC) 1272/2008 and as Xi, R38 and R41 according to Directive 67/548/EEC.
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