Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A prenatal developmental toxicity study was performed on an analogue substance. As no effects were observed in females in this study, no additional reproduction toxicity study was performed on the registered substance. NOAEL(maternal - analogue) > 1000 mg/kg bw/day ; NOAEL(maternal - registered substance, corrected by MM) > 1781.45 mg/kg bw/day

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 781.45 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Prenatal/developmental toxicity study performed on an analogue substance (OECD 414, GLP, rel.1).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No study was available on the substance itself, therefore a read-across approach was used.

In a Prenatal developmental toxicity study performed in accordance with OECD test guideline No. 414 and in compliance with GLP, an analogue substance was administered daily by oral gavage to SPF-bred Wistar rats (22 mated females per group) at dose levels of 100, 300 and 1000 mg/kg bw/day from day 1 post coitum (after mating) to day 20 post coitum (the day prior to Caesarean section). A control group was treated similarly with the vehicle, Milli-Q-Water. All females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. During the study, clinical condition, body weight, food consumption, macropathology investigations were undertaken on dams.

 

All dams survived until the scheduled necropsy. No clinical symptoms related to treatment with the test item were noted during the study. Mean food consumption, mean body weight and corrected body weight gain (corrected for the gravid uterus weight) were not affected by treatment with the test item in any dose group. Post-implantation losses and the mean number of fetuses per dam were not affected by treatment with the test item at any dose level. No macroscopical findings were noted during necropsy of the dams.

NOEL for maternal and fetal toxicity was considered to be 1000 mg/kg bw/day

 

Based on the results of this study performed on an analogue substance, the NOAEL of the registered substance for maternal toxicity was considered to be higher than 1781.45 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

Prenatal Developmental Toxicity Study on analogue substance (OECD 414, GLP, K, rel.1): NOAEL(analogue)= 1000 mg/kg bw/day ; NOAEL(registered substance, corrected by MM) = 1781.45 mg/kg bw/day

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 781.45 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study performed on an analogue substance is GLP-compliant and of high quality (Klimisch score = 1).
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

No study was available on the substance itself, therefore a read-across approach was used.

A key study was identified (Harlan, 2010). In a Prenatal developmental toxicity study performed in accordance with OECD test guideline No. 414 and in compliance with GLP, an analogue substance was administered daily by oral gavage to SPF-bred Wistar rats (22 mated females per group) at dose levels of 100, 300 and 1000 mg/kg bw/day from day 1 post coitum (after mating) to day 20 post coitum (the day prior to Caesarean section). A control group was treated similarly with the vehicle, Milli-Q-Water. All females were sacrificed on day 21 post coitum and the fetuses were removed by Caesarean section. During the study, external examination, sex ratios, body weights, visceral examination, skeletal and cartilage examination were performed on fetuses.

 

During the external examination of the fetuses, no test item-related abnormal findings were noted. No test item-related effects on fetal sex ratios were noted in any dose group. No test item-related effects on fetal body weights were noted. No test item-related abnormalities were noted during the visceral examination of fetuses. No abnormalities, which were considered to be test item-related, were noted during examination of fetal skeletons and cartilages.

NOEL for maternal and fetal toxicity was considered to be 1000 mg/kg bw/day

Based on the results of this study performed on an analogue substance, the NOAEL of the registered substance for fetal toxicity was considered to be higher than 1781.45 mg/kg bw/day.

Moreover, in the HERA report on Esterquats of November 2009, in a developmental toxicity study performed on Hamburg Ester Quat (HEQ), another analogue of the registered substance, the NOAEL is 1000 mg/kg bw/day ( maximum tested).

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:

Based on the available data, no self-classification is proposed regarding the toxicity on fertility or on development after oral dose-repeated exposure according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.