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Administrative data

Description of key information

 The key acute oral toxicity study was conducted according to OECD TG 423, and in compliance with GLP. The study reports an LD50 value of > 2000 mg/kg bw (Safepharm Laboratories, 1997). The key acute dermal toxicity study is read-across from the structurally analogous substance icosan-1-ol (CAS 629-96-9). The study was conducted according to generally acceptable scientific principles, but there is lack of information about GLP compliance. The study reports an LD50 value of > 16800 mg/kg (Smyth, 1969). No testing is required via inhalatory route since high reliability studies are already in place via the oral and dermal route. Furthermore, the LC50 for inhalation is expected to be greater than the substantially saturated vapour concentration based on weight of evidence across category.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 217-246g, females 206-223g
- Fasting period before study: overnight
- Housing: in groups of 3 by sex in solid - nfloor polypropylene cages furnished with wood flakes.
- Diet: Rat and Mouse expanded diet number 1, ad libitum
- Water: mains water, ad libitum
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-28
- Humidity (%): 49-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
other: suspension in arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200mg/ml
- Justification for choice of vehicle: Arachis oil BP was used as the test material did not dissolve or suspend in distilled water or other aqueous vehicles


MAXIMUM DOSE VOLUME APPLIED: 10ml/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
3M initially followed when it appeared the males would  survive by 3F, fasted
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for clinical signs of toxicity and  mortality 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily  throughout the observation period. Body weights were recorded prior to  dosing on day 0 and then at 7 and 14 days. 
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No clinical signs of systemic toxicity.
Body weight:
All animals  showed the expected body weight gain over the observation period except  for one female which showed a weight loss during the second observation  week. This was considered unlikely to be a toxicological effect.
Gross pathology:
Unremarkable
Other findings:
None reported (no sex specific differences, no potential target organs identified).
Interpretation of results:
GHS criteria not met
Conclusions:
The rat oral LD50 for Kalcol 220-80 is >2000 mg/kg. There were no signs of intoxication and no remarkable findings on gross necropsy.
Executive summary:

In the acute oral toxicity study, 2000 mg/kg of test material in arachis oil was administered orally to 3 male and 3 female rats. The rats were observed for clinical signs of toxicity at 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the 14 -day observation period. Body weights were also recorded prior to dosing on day 0 and then at 7 and 14 days. Necropsy of survivors was performed at the end of the 14 -day study period and macroscopic changes were noted.

No deaths were recorded throughout the observation period. No clinical signs of systemic toxicity were noted and there were no macroscopic abnormalities at necropsy. The study reports an LD50 value of > 2000 mg/kg bw. The study was conducted according to an appropriate OECD test guideline, and in complance with GLP.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Remarks:
result reporting is limited
Principles of method if other than guideline:
Method: other: Smyth et al, 1962
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
- Source: no data
- Weight at study initiation: 2.5 -3.5 kg
- Group size: 4
- Controls: no



Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- Area covered: entire trunk

No. of animals per sex per dose:
4
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.

Results were not reported in detail. The LD50 was >20 ml/kg. (>16,800 mg/kg using the density of 0.84 g/cm3 reported in chapter 2.3). No further 

details available.

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of >20 ml/kg is reported in a relaible study conducted according to appropriate protocol. The study is a read across from 1-icosanol (CAS 629-96-9).
Executive summary:

In an acute dermal toxicity study, the test material (icosan-1 -ol) was applied onto rabbit skin and kept in contact to the skin for 4 hours under occlusive dressing. There is lack of detail on the materials and methods used, as well as results, however the study reports an LD50 value of > 20 ml/kg (>16,800 mg/kg using the density of 0.84 g/cm3 reported in chapter 2.3). The study meets generally accepted scientific principles, acceptable for assessment. Study considered valid although result reporting is limited. The study is a read across from icosan-1-ol (CAS 629-96-9).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
16 800 mg/kg bw

Additional information

The key acute oral toxicity study was conducted according to OECD TG 423, and in compliance with GLP. The study reports an LD50 value of > 2000 mg/kg bw (Safepharm Laboratories, 1997).

Following oral administration of 2000 mg/kg bw of test material in arachis oil to 3 male and 3 female rats, no mortalities, clinical signs of toxicity or changes in body weight gain were recorded during the 14 -day observation period.

The key acute dermal toxicity study is read-across from the structurally analogous substance icosan-1-ol (CAS 629-96-9). The study was conducted according to generally acceptable scientific principles, but there is lack of information about GLP compliance. The study reports an LD50 value of > 16800 mg/kg (Smyth, 1969).

The test material was applied onto rabbit skin and kept for 4 hours under occlusive dressing. The study lacks full details on materials and methods, as well as results.

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Acute toxicity tests of the linear and essentially linear alcohols do not indicate any potential hazard for acute, dermal or inhalation toxicity. The available data for the Category have been reviewed with the conclusion that the long chain alcohols are of a low order of acute oral and dermal toxicity, and the inhalation LC50 is expected to be greater than the substantially saturated vapour concentration (Veenstra G, Webb C et al., 2009). Tests on various substances included in this category are all supportive of these results and do not warrant classification for most of the acute toxicity endpoints under GHS criteria. The majority of the substances are therefore not classified for acute toxicity in accordance with Regulation (EC) No 1272/2008. The only exception to this is hexan-1-ol, which finds that the acute dermal data for the test substance are consistent with Acute dermal tox category 4 and Acute oral tox 4 H302/R22, in line with the Annex VI entry. A full discussion of the Category can be found in the Human Health Alcohols C6-24 Category report (PFA, 2016).


Justification for selection of acute toxicity – oral endpoint
The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Justification for selection of acute toxicity – dermal endpoint
The study meets generally accepted scientific principles. Study is considered valid although result reporting is limited. The study is a read across from icosan-1-ol (CAS 629-96-9).

Justification for classification or non-classification

Based on the available data, docosan-1-ol does not require classification for acute toxicity according to Regulation (EC) No 1272/2008.