Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A skin irritation and an eye irritation study, both guideline studies, are available for the test item:
- Skin irritation study (Henkel R 9300103, 1993) with 3 rabbits, according to the OECD TG 404, GLP-conform.
- Eye irritation study (Henkel R 9300255, 1993) with 3 rabbit, according to the OECD TG 405, GLP-conform.
In addition, supporting information from an in vitro EpiDerm Skin Corrosion / Irritation Test (BASF 61V0276/12A161, 2012) and an in vitro HET-CAM assay with fertilized chicken eggs (Henkel R 9300036, 1993) are also available.
The findings of the OECD TG 404 skin irritation study indicated that the test item was irritating to the skin of rabbit. However, with respect to classification according to the EU Directive 67/548/EEC and to the CLP Regulation (EC) No. 1272/2008, the current criteria for classification are not fulfilled and thus, the substance has not to be classified as skin irritant. The results of an in vitro EpiDerm Skin Corrosion/Irritation Test, however, gave no indication for skin irritation. Thus, the test substance is considered non-irritating to the skin.
The findings of the OECD 405 eye irritation study gave no indication for eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

The test item was tested for skin irritation in 3 rabbits, under semi-occlusive conditions, according to the OECD TG 404 (Henkel R 9300103). After 4 h exposure, the animals were observed for up to 21 days, with the skin being examined for signs of irritation at the following reading time points: 1, 24, 48 and 72 h, day 7, day 14 and day 21. The skin findings were assessed by scoring according to the Draize scoring system.

At reading time point 1 h, all 3 animals displayed erythema and edema ranging from grade 1 to 2. After 24 hours, one animal displayed erythema and edema of grade 3, respectively and showed brownish discolouration; the 2 remaining animals had erythema and edema not exceeding grade 2 in severity, without any discolouration. At reading time point 48 h, the first animal still displayed skin reaction as described for 24 h. One of the 2 remaining animals showed erythema and edema of grade 1, respectively, whereas the second animal only showed erythema. At reading time point 72 h, the first animal still displayed skin reaction as described for 24 and 48 h. Both remaining animals showed erythema and edema of grade 1. After 7 days, no reversibility could be evidenced in any of the 3 animals. They all showed eschar formation and the first animal also showed a small shiny trip whereas another animal showed brownish discolouration. After 14 days, the first animal with the more severe findings still showed skin reaction as seen after 7 days, except for eschar. In contrast, full reversibility was achieved in the 2 remaining animals. After 21 days, the one animal with the more severe findings still showed erythema and edema graded 1, respectively, indicating that full reversibility was not achieved.

The mean erythema and edema scores from all 3 animals over the reading time points 24, 48 and 72 h which are relevant for assessment were 1.6 for erythema and 1.6 for edema. At day 14, full reversibility was achieved in 2/3 animals. Thus, the findings indicate that the test item was slightly irritating to the skin of the rabbits.

Supporting information from an in vitro EpiDerm Skin Corrosion/Irritation Test performed according to OECD guidelines 431 and 439 under GLP conditions (BASF 61V0276/12A161, 2012) is available. Reconstructed three dimensional human epidermis was treated with the undiluted test substance (85.1% pure) for 3 and 60 min (Corrosion test) or 60 min followed by a 42-h post-incubation period (Irritation test). To evaluate the skin irritating potential, cell viability was measured via an MTT assay and was expressed as percentage of the negative control (de-ionized water in the Corrosion test and PBS in the Irritation test).

In the Corrosion tests, two tissues per condition were analysed and 8 N KOH served as positive control. The mean cell viability after treatment with 50 µL of the test substance was 102% and 98% after 3 and 60 min, respectively. In the Irritation test, three tissues per condition were analysed and 5% SDS was used as positive control. The mean cell viability after treatment with 30 µL of the test substance was 98%. Thus, the test substance was neither corrosive nor irritant to the reconstructed human skin in this in vitro study. 

Eye irritation

The test item was further tested for eye irritation in 3 rabbits, according to the OECD TG 405 (Henkel R 9300255). After 24 h exposure, the treated eyes were washed and the animals were observed for 72 hours, with the eyes being examined for signs of irritation at the following reading time points: 1, 24, 48 and 72 h. The findings were assessed by scoring according to the Draize scoring system.

Following treatment, the first test animal displayed erythema grade 1 accompanied by discharge grade 2 at reading time point 1 h only. The second animal showed no eye reaction at all, whereas the third one had discharge grade 2 at reading time point 1 h, and conjunctival redness at 24 h, respectively. Thus, the test item was not irritating to the eyes of the rabbits.

The test item was further subjected to the in vitro HET-CAM assay and was applied onto the chorioallantoic membrane of fertilized chicken eggs; Texapon ASV (5% a.i.) served for reference substance (Henkel R 9300036). In a pretest, the test material induced weak hemorrhage on the CAM after 200 seconds. In the main test, the irritation potential of the test item was determined as 0.00 whereas for the reference substance, it was 1.00. Thus, it was concluded that the undiluted test item is not corrosive.

Justification for classification or non-classification

Taking into account the available data, no classification according to the EU Directive 67/548/EEC and to the CLP Regulation (EC) No. 1272/2008 is warranted for "alcohols, C6 -C24 and C6 -C24 unsat., distn residues" (CAS 102242 -48 -8) regarding skin and eye irritation.