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Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 2000 mg/kg bw

Read-across from structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6)

Inhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1600 mg/m³ (maximum technically attainable concentration)

WoE approach referring to the structural analogue substances Alcohols, C10-16, ethoxylated (CAS 68002-97-1) and 2-[2-(hexyloxy)ethoxy]ethanol (CAS 112-59-4)


Dermal (OECD 402), rat/rabbit: LD50 > 2000 mg/kg bw

WoE approach referring to the structural analogue substances Alcohols, C10-16, ethoxylated (CAS 68002-97-1) and 2-[2-(hexyloxy)ethoxy]ethanol (CAS 112-59-4), Alcohols, C6-12, ethoxylated (CAS 68439-45-2), Alcohols, C12-13, ethoxylated (CAS 66455-14-9), Alcohols, C12-14, ethoxylated (CAS 68439-50-9), and Alcohols, C12-15, ethoxylated (CAS 68131-39-5)


Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Source, key, 68439-49-6, 1986a
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
An LD50 value > 2000 mg/kg bw has been determined for male and female rats.
Executive summary:

The acute oral toxicity of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance Alcohols, C16-18, ethoxylated (CAS 68439-49-6). The LD50 as determined for the source substance is > 10000 mg/kg bw for male and female rats. Therefore, a LD50 value of > 2000 mg/kg bw for the target substance is considered for the hazard assessment and C&L purposes. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 600 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Source, WoE, 68002-97-1, 1982a
Remarks:
Maximum attainable concentration.

Additional study considered in the Weight-of-Evidence approach:

CAS 112-59-4, Ballantyne, 1987: LC50 (6 h, rat, m/f) > 100 mg/m3 air (effect level represents calculated saturated vapour)

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The inhalation LC50 values determined are > 100 mg/m3 air an > 1600 mg/m3 air for male and female rats. The values represent the maximum attainable concentration and the calculated saturated vapour pressure of the test materials, respectively.
Executive summary:

The acute inhalation toxicity of the target substance is estimated based on two adequate and reliable in vivo studies from structural analogue source substances Alcohols, C10-16, ethoxylated (CAS 68002-97-1) and 2-[2-(hexyloxy)ethoxy]ethanol (CAS 112-59-4). The inhalation LC50 values determined are > 100 mg/m3 air and > 1600 mg/m3 air for male and female rats. The values represent the maximum attainable concentration and the calculated saturated vapour pressure of the test materials, respectively. Therefore, no hazard for the target substance is identified and C&L is set accordingly. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the acute inhalation toxicity

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
Refer to the analogue justification provided in IUCLID6 section 13
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Source, WoE, 68002-97-1, 1982b

Additional data considered in a Weight-of-Evidence approach:

CAS 112-59-4, Ballantyne, 1987: LD50 (rabbit, m) = 2000 mg/kg bw

CAS 68439-45-2, Shell, 1979a, LD50 (rat, m/f) > 2000 mg/kg bw

CAS 66455-14-9, Shell, 1979b, LD50 (rat, m/f) > 2000 mg/kg bw

CAS 68439-50-9, Huntsman, 1990, LD50 (rat, m/f) > 3000 mg/kg bw

CAS 68131-39-5, Shell, 1978, LD50 (rat, m/f) > 2000 mg/kg bw

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Individual LD50 values determined in male and female rabbits are >/= 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the target substance is estimated based on adequate and reliable in vivo studies from several structural analogue source substances. LD50 values determined in the different studies range from 2000 mg/kg bw to > 3000 mg/kg bw for male and female rabbits. Therefore, a LD50 value of > 2000 mg/kg bw for the target substance is considered for the hazard assessment and C&L purposes. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

No data on acute toxicity of the target substance C16AE (CAS 9004-95-9) are available. Hence, to cover the endpoint, studies from similar substances were considered for read-across or in a weight-of-evidence approach. Read-across is justified because the length of the alkyl chain does not exert any meaningful influence on acute toxicity, whereas the degree of ethoxylation is of more importance. Up to the level of EO = 4, which includes all read-across substances, the toxicity is low (HERA, 2009).

 

Acute oral toxicity

No data regarding acute oral toxicity are available for C16AE (CAS 9004-95-9). Therefore, acute oral toxicity was addressed using reliable data (Sasol, 1986a) as available from the structurally-related substance C16-18AE (CAS 68439-49-6) for read-across. The study was conducted according to OECD Guideline 401. In this limit test five Wistar rats per sex received 10,000 mg/kg bw. No mortalities occurred, resulting in a LD50 value of greater than 10,000 mg/kg bw. Clinical signs comprised piloerection only. Moreover, necropsy revealed no effects.

Acute inhalation toxicity

No data regarding acute inhalation toxicity are available for the target substance. Thus, as for the oral route, suitable data from analogue substances are considered. In fact, there are two studies available addressing acute inhalation toxicity, being performed with C10-16AE (CAS 68002-97-1) and C6-10AE (CAS 112-59-4) and equivalent to OECD Guideline 403.

In the first study (Sasol, 1982a) with C10-16AE (CAS 68002-97-1) five Sprague Dawley rats/sex were exposed for a period of 4 h to an aerosol of the test substance at a concentration of 1600 mg/m³ (corresponding to 1.6 mg/L), which is the maximum technically attainable concentration of the test substance with a MMAD < 4 µm (limit test). No mortality occurred during the exposure or the 14-day observation period. The animals demonstrated clinical signs of toxicity like slight nasal discharge and lacrimation during exposure as well as slight, red nasal discharge post-exposure. The LC50 was determined to be greater than 1600 mg/m³ for exposure to an aerosol of the test substance for 4 h.

In the second study (Ballantyne, 1987) five Wistar rats per sex were exposed for a period of 6 h to a vapour of the test substance at the calculated saturated vapour concentration of 100 mg/m³. No mortality or clinical signs occurred during the exposure period. The LC50 was determined to be greater than 100 mg/m³ for exposure to an aerosol of the test substance for 6 h.

 

Acute dermal toxicity

No data regarding acute dermal toxicity are available for C16AE (CAS 9004-95-9). Therefore acute dermal toxicity was addressed using reliable data as available from structurally related substances C6-10AE (CAS 112-59-4), C6-12AE (CAS 68439-45-2), C10-16AE (CAS 68002-97-1), C12-13AE (CAS 66455-14-9), C12-15AE (CAS 68131-39-5) and C12-14AE (3EO, CAS 68439-50-9) in a weight-of-evidence approach.

 

The first study (Sasol, 1982b) conducted with C10-16AE (CAS 68002-97-1) was a limit test conducted equivalent to OECD Guideline 402. In this limit test five New Zealand White rabbits per sex received 2000 mg/kg bw for a 24 h-occluded exposure. No mortalities occurred. Hence, the LD50 value was set to greater than 2000 mg/kg bw.

 

A further study (Ballantyne, 1987) with C6-10AE (CAS 112-59-4) equivalent to OECD Guideline 402 was carried out on five New Zealand White rabbits per sex and dose. Both sexes were dosed at 900, 1900 and 3700 mg/kg bw under occlusive conditions for 24 h, with the females receiving an additional dose of 2600 mg/kg bw. Mortalities occurred at a dose level of 1900 mg/kg bw and above, resulting in a LD50 of 2000 mg/kg bw for males and 2216 mg/kg bw for females, respectively. Moreover, necropsy revealed dark red or dark pink lungs in the deceased animals.

 

Another study (Shell, 1979a) regarding acute dermal toxicity was conducted with C6-12AE (CAS 68439-45-2). This limit test was conducted equivalent to OECD Guideline 402; however, only four Wistar rats per sex were used. The dose level of 2000 mg/kg bw was applied occlusive for 24 h and caused neither treatment-related clinical signs nor mortalities. Hence, the LD50 was determined to be greater than 2000 mg/kg bw.

With C12-13AE (CAS 66455-14-9), a study (Shell, 1979b) according to OECD Guideline 402 was carried out on four Wistar rats per sex and dose. Both sexes were dosed at 1000, 2000 and 4000 mg/kg bw under occlusive conditions for 24 h. Mortalities occurred at a dose level of 2000 mg/kg bw and above, resulting in a LD50 of greater than 2000 mg/kg bw and approximately 4000 mg/kg bw. Rats showed at all dose levels hyperactivity to stimuli. In the deceased, additional symptoms like lethargy, dyspnoea and greasy soiled fur as well as a progressive loss of body weight were observed.

 

A study (Huntsman, 1990) conducted with C12-14AE (3EO, CAS 68439-50-9) was performed as limit test conducted similar to OECD Guideline 402. In this limit test five New Zealand White rabbits per sex received 3000 mg/kg bw for a 24 h-occluded exposure. No mortalities occurred, hence, the LD50 value was set to greater than 2000 mg/kg bw.

 

In the last study (Shell, 1978) regarding acute dermal toxicity, a limit test with C12-15AE (CAS 68131-39-5) was conducted equivalent to OECD Guideline 402. Four Wistar rats per sex were exposed occlusive to 2000 mg/kg bw for 24 h and caused neither treatment-related clinical signs nor mortalities. Hence, the LD50 was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP), the substance does not need to be classified for acute toxicity.