Octan-1-ol

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to birds: dietary toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Studies conducted according to sound scientific principles, no GLP nor analytical monitoring.

Qualifier:

no guideline followed

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 223 (Avian Acute Oral Toxicity Test)

Deviations:

not applicable

GLP compliance:

not specified

Dose method:

feed

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and analysis of diet:

DIET PREPARATION

- Description and nutrient analysis of basal diet provided in study report: yes

- Preparation of doses: The test substance and dieldrin (positive control) were dissolved in corn oil in concentrations such that the addition of two parts (by weight) of each solution to 98 parts of the standard game bird starter ration resulted in the logarithmic series of dosage levels defined in Table 2.

Test organisms (species):

other: Anas platyrhynchos (duck) and Colinus virginianus (quail)

Details on test organisms:

- Common name: Mallard duck (Anas platyrhynchos) and bobwhite quail (Colinus virginianus)

- Source: Production flock, Truslow Farms Inc., Chestertown, Maryland

- Age at test initiation: 14 days, both species

- Disease free: yes

Limit test:

no

Total exposure duration (if not single dose):

5 d

Post exposure observation period:

3 days

No. of animals per sex per dose and/or stage:

5 pens per treatment, 5 birds per pen.

Control animals:

yes, plain diet

Nominal and measured doses / concentrations:

See Table 1.

Details on test conditions:

ACCLIMATION

- Acclimation period: the eggs were incubated in a Chick master (Model 52E) for 23 days (quails) and 25 days (ducks), upon hatching the chicks were placed in Beacon (Model B755) battery broodes until they were 14 days of age.

- Acclimation conditions (same as test or not): temperature was the same (ca. 99.0 degF)

- Feeding: basal diet was Truslow Farms' game bird starter ration, available ad libitum

- Health (any disease or mortality observed): none reported

- Fasting period before study: none


FEED WITHHOLDING PERIOD BEFORE DOSING

- No. of days: none


PEN SIZE AND CONSTRUCTION MATERIALS

- Caging: group


NO. OF BIRDS PER REPLICATE

- For negative control: 10

- For vehicle control: 10

- For treated: 10


NO. OF REPLICATES PER GROUP

- For negative control: 5

- For vehicle control: 1

- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)

- Temperature:

- Brooder temperature: ca. 99 degF

Details on examinations and observations:

MORTALITY / CLINICAL SIGNS

- Time schedule for examinations: daily


BODY WEIGHT

- Time schedule for examinations: beginning and end of test.



FOOD CONSUMPTION (if feeding study)

- Time schedule for examinations: daily

Reference substance (positive control):

yes

Remarks:

dieldrin

Duration (if not single dose):

5 d

Dose descriptor:

LC50

Effect level:

> 10 000 other: ppm

Conc. / dose based on:

other: nominal conc. of test material

Basis for effect:

mortality

Remarks on result:

other: bobwhite quail and mallard duck

Mortality and sub-lethal effects:

For details on cumulative mortality and sub-lethal effects see Tables 2 and 3.

MORTALITY: 20% bobwhite quail, 0% mallard duck


BODY WEIGHT

- Results: The bobwhite quail suffered a decrease in body weight gain, no statistical analysis provided. No effects were seen for in the duck test. See Tables 2 and 3.


FOOD CONSUMPTION

- Results: The bobwhite quail suffered a decrease in food consumption, no statistical analysis provided. No effects were seen for in the duck test. See Tables 2 and 3.

Results with reference substance (positive control):

BOBWHITE QUAIL:

- Results with reference substance valid? yes

- Relevant effect levels: LC50 = 31 ppm (95% confidence limits: 24-39 ppm)

- Other:


MALLARD DUCK:

- Results with reference substance valid? yes

- Relevant effect levels: LC50 = 97 ppm (95% confidence limits: 69-135 ppm).

- Other: There was a dose-related suppression in body weight gain and food consumption. At 68 ppm dosage level, only hyperexcitability was observed prior to death. The following symptoms of toxicity were observed at 100, 147, 215 and 316 ppm: lack of coordination, depression, loss of the righting relfex, rigidly extended legs and necks, and salivation.

Reported statistics and error estimates:

Mortality was analysed statistically by the method of Litchifield J T and Wilcoxon F J (1949) Pharmacol. Exptl. Therap. 96: 99

Table 2. Mortality, average body weight (per pen) and total food consumption (during the 5 d exposure period) for the bobwhite quail.

Nominal concentration (ppm)	Mortality (%)	Average body weight (g)		Total estimated food consumption (g)
		day 0	day 8
0	0	30	46	530
464	0	25	38	500
1,000	0	27	44	525
2,150	0	25	37	575
4,640	0	25	38	675
10,000	20	25	30	475

Table 3. Mortality, average body weight (per treatment) and total food consumption (during the 5 day exposure) for the mallard duck.

Nominal concentration (ppm)	Mortality (%)	Average body weight (g)		Total estimated food consumption (g)
		day 0	day 8
0	0	165	329	4,580
464	0	185	395	4,400
1,000	0	185	390	4,425
2,150	0	190	385	5,100
4,640	0	190	405	3,890
10,000	0	175	370	3,475

Validity criteria fulfilled:

yes

Conclusions:

A 5 day LC50 value equivalent to >10,000 ppm (expressed as nominal concentration in the diet) has been determined for the effects of the test substance on mortality of Mallard duck and Bobwhite quail.

Reference 2

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

The result was obtained from a collection of reliable data which has been subject to peer-review and in which the original data sources are traceable.

Qualifier:

no guideline followed

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 223 (Avian Acute Oral Toxicity Test)

Deviations:

not applicable

GLP compliance:

not specified

Dose method:

feed

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

other: Gallus gallus domesticus

Details on test organisms:

TEST ORGANISM

- Common name: chicken

Limit test:

no

Total exposure duration (if not single dose):

21 d

Control animals:

not specified

Reference substance (positive control):

not specified

Duration (if not single dose):

21 d

Dose descriptor:

LD50

Effect level:

201 000 other: ppm

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Duration (if not single dose):

21 d

Dose descriptor:

NOEC

Effect level:

200 000 other: ppm

Conc. / dose based on:

test mat.

Basis for effect:

mortality

Further details on results:

Mortality was observed at lower concentrations.

The US EPA is a peer reviewed online database source for ecotoxicological studies conducted globally. While full details on the study are not reported, the database does provide an indication of the study that was conducted. In this case the study is only supporting therefore full details are not required.

Validity criteria fulfilled:

not specified

Conclusions:

A reliable 21 day LD50 value of 201,000 ppm has been determined for the effects of decanol on the mortality of the bird Gallus domesticus. Full details of the study are not available.

Reference 3

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The result was obtained from a collection of reliable data which has been subject to peer-review and in which the original data sources are traceable.

Qualifier:

no guideline available

Principles of method if other than guideline:

Method: The birds were given a single oral dose via capsule, then observed for 14 days.

GLP compliance:

not specified

Dose method:

capsule

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Anas platyrhynchos

Limit test:

no

Total exposure duration (if not single dose):

14 d

Control animals:

yes

Reference substance (positive control):

not specified

Duration (if not single dose):

14 d

Dose descriptor:

LD50

Effect level:

> 4 640 mg/kg bw

Basis for effect:

mortality

Validity criteria fulfilled:

not specified

Reference 4

Endpoint:

long-term toxicity to birds

Remarks:

long-term or reproductive testing

Data waiving:

other justification

Justification for data waiving:

other:

Description of key information

Short-term: LC₅₀ (5 d) >10,000 ppm A. platyrhynchos (duck) and C. virginianus (quail).

Long term: In accordance with Column 2 of REACH Annex X the study does not need to be conducted, based on the mammalian data available.

Additional information

Short-term toxicity

Only short term oral toxicity data to birds exists, read-across from the close structural analogue decan-1-ol (CAS 112-30-1).

A 5 day LC₅₀ value equivalent to >10,000 ppm (expressed as nominal concentration in the diet) has been determined for the effects of the test substance on mortality of Anas platyrhynchos (mallard duck) and Colinus virginianus (bobwhite quail) (Truslow Farms Inc., 1975).

A 14-d LD₅₀ of >4640 mg/kg bw has been determined for the effects of the test substance on mortality of Anas platyrhynchos (mallard duck) (EEDB, 1995).

A 21-d LD₅₀ of 201000 ppm and a NOEC of 200000 ppm have been determined for the effects of the test substance on mortality of Gallus domesticus (chicken) Yoshida et al., 1971).

However none have been selected as key since ECHA (2011, Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment Dec 2011, version 2.1) reads: "due to poor correlation between short and long term effects, only long term studies are considered suitable for CSA purposes".

Long-term toxicity

In accordance with Column 2 of REACH Annex X, studies on long-term or reproductive toxicity to birds (required in section 9.6.1) do not need to be conducted due to the existence of mammalian data demonstrating no long term systemic effects to higher organisms. Secondary poisoning assessment is not required for this substance because the substance is readily biodegradable, the potential for bioaccumulation is low (BCF = 9.1 L/kg) and mammalian toxicity data indicate that the substance does not have a potential to cause toxic effects if accumulated in higher organisms.

Justification for Read-across

1. HYPOTHESIS FOR THE CATEGORY APPROACH

The hypothesis is that the category members have similar structures and properties, and toxicity to birds effects, which vary in strength across the category, forming a regular pattern (Scenario 4 in the RAAF). The interpretation of the observed trends of variation of this property across the category is discussed in the endpoint summary.  

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Please refer to the test material identity information within each endpoint study record.

The long chain linear aliphatic alcohol Category has at its centre an homologous series of increasing carbon chain length alcohols. The category members are structurally very similar. They are all primary aliphatic alcohols with no other functional groups. The category members are linear or contain a single short-chain side-branch at the 2-position in the alkyl chain, which does not significantly affect the properties (‘essentially linear’). The category members have saturated alkyl chains or contain a small proportion of naturally-occurring unsaturation(s) which does not significantly affect the properties. The branched and unsaturated structures are considered to have such similar properties that their inclusion in the category is well justified.

Impurities: Linear and/or ‘essentially linear’ long chain aliphatic alcohols of other chain lengths may be present. These are not expected to contribute significantly to the properties in respect of this endpoint due to predictable trends (see point 3).  

There are no impurities present at above 1% which are not category members or which would affect the properties of the substance.

3. CATEGORY JUSTIFICATION

The category members are structurally very similar (see point 2) and are biochemically very similar. The metabolic synthesis and degradation pathways are well established. This Category is associated with a consistency and predictability in the physicochemical, environmental, and toxicological property data across its members.

The context of trends observed in this property across the range of chain lengths covered by this Category is described in the Endpoint Summary and in the Category Report attached in Section 13.

In this registration, the information requirement is interpolated based on read-across from members of the category with  longer chain length, providing evidence of the range of values expected for the registration substance.