Alcohols, C16-18

Toxicity to other above-ground organisms

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to other above-ground organisms

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.

Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.

Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EPA OPP 71-3 (Wild Mammal Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

yes

Test organisms (species):

rat

Details on test organisms:

TEST ORGANISMS:
Rattus norvegicus (Norway Rat). The sexually mature organism(s) (age: 68-85 d and organism characteristics of: 365.1 G,PREGNANT, OUTBRED STRAIN/)

Study type:

laboratory study

Limit test:

no

Total exposure duration:

20 d

Test temperature:

10-20 0C
Temperature was continuously recorded

Photoperiod and lighting:

They were held at a photoperiod of 14:10 light:dark.

Nominal and measured concentrations:

DOSES/130/650/975/1300 mg/kg/d

Reference substance (positive control):

not specified

Duration:

10 d

Dose descriptor:

other: NOEL

Effect conc.:

130 mg/kg bw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: NR-ZERO was reported (NOEL) Zero Mortality: 0% mortality or 100% survival of organisms. (No statistically derived endpoint reported)

Duration:

10 d

Dose descriptor:

NOEC

Effect conc.:

2 600 mg/kg diet

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

TheNOELs can be converted to NOECs with the following two formulae:   NOECrat=NOELrat.CONVrat   Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)  

Basis for effect:

mortality

Remarks on result:

other: NOECrat=130 x 20=2600 mg/kg/diet Conversion factors from NOEL to NOEC for mammalian species Rattus norvegus >6 weeks is 20 (bw/dfi) bw = body weight (g); dfi: daily food intake (g/day)  

Duration:

20 d

Dose descriptor:

other: NOEL

Effect conc.:

1 300 mg/kg bw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks:

Measurement: Abnormal,Weight;

Duration:

20 d

Dose descriptor:

NOEC

Effect conc.:

26 000 mg/kg diet

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

TheNOELs can be converted to NOECs with the following two formulae:   NOECrat=NOELrat.CONVrat   Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)  

Basis for effect:

behaviour

Remarks:

Measurement: Abnormal,Weight;

Remarks on result:

other: NOECrat=1300 x 20=26000 mg/kg/diet Conversion factors from NOEL to NOEC for mammalian species Rattus norvegus >6 weeks is 20 (bw/dfi) bw = body weight (g); dfi: daily food intake (g/day)  

Details on results:

The NOEL for the  Rattus norvegicus  was 130 mg/kg bw for mortality
The NOEL for the  Rattus norvegicus  was 1300 mg/kg bw for Abnormal and Weight effects
For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food in order to be able to compare it to the PEC.

TheNOELs can be converted to NOECs with the following two formulae:
 
NOECrat=NOELrat.CONVrat
 
Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)
 
bw = body weight (g); dfi: daily food intake (g/day)
 
NOECrat=130 x 20=2600 mg/kg/diet

A study of NC-NC Not Coded duration using no substrate media was conducted in a Lab site location with Not Coded obtained Rattus norvegicus (Norway Rat). The sexually mature organism(s) (age: 68-85 d and organism characteristics of: 365.1 G,PREGNANT, OUTBRED STRAIN/) were exposed for a duration of 10 day(s) to a(n) 10 Daily for X days application of 1-Octanol (CAS # 111875) in NR carrier or a(n) NR positive control through a(n) gavage exposure route. The reported chemical concentrations are the result of unmeasured analysis of chemical solutions and are based on the NR ion. (Reference 84162, Hellwig, J., and R. Jackh, 1997, Test Number 406282).

Validity criteria fulfilled:

yes

Conclusions:

The NOEL for the  Rattus norvegicus  was 130 mg/kg bw for mortality
The NOEL for the  Rattus norvegicus  was 1300 mg/kg bw for Abnormal and Weight effects
For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food in order to be able to compare it to the PEC.

TheNOELs can be converted to NOECs with the following two formulae:
 
NOECrat=NOELrat.CONVrat
 
Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)
 
bw = body weight (g); dfi: daily food intake (g/day)
 
NOECrat=130 x 20=2600 mg/kg/diet

Executive summary:

The NOEL for the  Rattus norvegicus  was 130 mg/kg bw for mortality The NOEL for the  Rattus norvegicus  was 1300 mg/kg bw for Abnormal and Weight effects For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food in order to be able to compare it to the PEC. TheNOELs can be converted to NOECs with the following two formulae:   NOECrat=NOELrat.CONVrat   Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)   bw = body weight (g); dfi: daily food intake (g/day)   NOECrat=130 x 20=2600 mg/kg/diet

Reference 2

Endpoint:

toxicity to other above-ground organisms

Data waiving:

other justification

Justification for data waiving:

other:

Description of key information

The NOEL for the  Rattus norvegicus  was 130 mg/kg bw for mortality 
The NOEL for the  Rattus norvegicus  was 1300 mg/kg bw for  Abnormal and Weight effects
For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food in order to be able to compare it to the PEC.
TheNOELs can be converted to NOECs with the following two formulae:
 
NOECrat=NOELrat.CONVrat
 
Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)
 
bw = body weight (g); dfi: daily food intake (g/day)
 
NOECrat=130 x 20=2600 mg/kg/diet

Key value for chemical safety assessment

Short-term EC50 or LC50 for mammals:

13 000 mg/kg food

Long-term EC10, LC10 or NOEC for mammals:

2 600 mg/kg food

Additional information

The NOEL for the  Rattus norvegicus  was 130 mg/kg bw for mortality

The NOEL for the  Rattus norvegicus  was 1300 mg/kg bw for Abnormal and Weight effects

For the assessment of secondary poisoning, the results always have to be expressed as the concentration in food in order to be able to compare it to the PEC.

TheNOELs can be converted to NOECs with the following two formulae:  

NOECrat=NOELrat.CONVrat  

Conversion factors from NOEL to NOEC for mammalian species Rattus norvegicus (> 6 weeks) is 20 (bw/dfi)   bw = body weight (g); dfi: daily food intake (g/day)  

NOECrat=130 x 20=2600 mg/kg/diet