Reaction mass of 2-hydroxy-3-[(1-oxodocosyl) oxy]propyltrimethylammonium chloride and 2-methylpentane-2,4-diol

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats, GLP, rel.2, K)

Acute toxicity: dermal: LD50 > 9099 mg/kg bw (similar to OECD 402, pre-GLP, rel.4, S)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was a GLP study conducted in compliance with OECD Guideline No. 401 with deviations: purity of test substance not reported. This study was considered sufficiently robust to cover this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

9 099 mg/kg bw

Quality of whole database:

The study performed on the registered substance in rats was pre-GLP and was of poor quality (Klimish score = 4) but as no deaths were observed in acute oral toxicity and skin irritation studies, the results are considered to be in accordance with the whole data.

Additional information

Acute toxicity: oral

A key study was identified (Notox, 1987, rel.2). In this limit acute oral toxicity study, which was performed according to OECD Guideline No. 401 and in compliance with GLP, a group (5/sex/dose) of Wistar rats was treated with the test material at a dose level of 2000 mg/kg bw. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

No mortality and no signs of systemic toxicity was observed during the 14 -day observation period. All animals showed body weight gain during the study period. No abnormalities were noted at necropsy.

This study gave an estimated oral LD50 (rats) > 2000 mg/kg bw.

Moreover, in the HERA report on Esterquats of November 2009, in an acute oral toxicity study performed on Hamburg Ester Quat (HEQ), another analogue of the registered substance, the LD50 is > 5000 mg/kg bw.

Reference: HERA (2009). Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products (HERA), Avenue Herrmann Debroux ISA, B-1160 Brussels Belgium. Edition 1.0 November 2009. Esterquats Human Health Risk Assessment Report. <http://www.heraproject.com/files/17-HH-HERA-EQ-HH-TM-finalDraft-24Nov%20web.pdf>.

Acute toxicity: dermal

A key study was identified (TNO, 1981, rel.2). In this acute dermal toxicity study, which was performed similarly to OECD Guideline No. 402, groups (2/sex/dose) of NZW rabbits were treated to a large surface of skin with the test material at 5, 10 or 100%, at 9 mL/kg bw during 24 hours, which is equivalent to 455, 910 and 9099 mg/kg bw. In each dose group one male and one female received the test substance on the intact skin, while the other male and female was treated on the superficially damaged skin.

The animals were observed for mortality, clinical signs, body weight, food and water consumption and haematology for 14 days and then necropsied for macroscopic observations.

No treatment-relatied mortality was observed during the 14-day observation period. After the exposure, only one top-dose animal showed signs of skin irritation. Other parameters were not altered by the treatment. No abnormalities were noted at necropsy.

This study gave an estimated dermal LD50 (rabbits) > 9099 mg/kg bw.

Moreover, in the HERA report on Esterquats of November 2009, in an acute dermal toxicity study performed on Hamburg Ester Quat (HEQ), another analogue of the registered substance, the LD50 is > 2000 mg/kg bw.

Reference:HERA (2009). Human and Environmental Risk Assessment on Ingredients of Household Cleaning Products (HERA), Avenue Herrmann Debroux ISA, B-1160 Brussels Belgium. Edition 1.0 November 2009. Esterquats Human Health Risk Assessment Report. <http://www.heraproject.com/files/17-HH-HERA-EQ-HH-TM-finalDraft-24Nov%20web.pdf>.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Acute toxicity via Oral route:

Based on the available information, the substance is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw

- not classified according to the GHS since there is no reliable evidence that indicates the LD50 is within the Category 5 (GHS criteria not met)

Acute toxicity via Dermal route:

Based on the available data, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the oral LD50 is expected to be greater than 5000 mg/kg bw.

Acute toxicity (Inhalation):

No data was available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.

Specific target organ toxicity: single exposure (Dermal):

Based on available data via both the oral and dermal route, the classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single dermal exposure Category 1 or 2 are not considered to be met. No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute dermal toxicity study.

Specific target organ toxicity: single exposure (Inhalation):

No data was available.