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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral
• A reliable (Klimisch 1) OECD 401 GLP compliant study with icosan-1-ol. LD50 >10000mg/kg
• A reliable (Klimisch 1) OECD 423 GLP compliant study with docosan1-1ol. LD50 >2000mg/kg
• A reliable (Klimisch 2) guideline equivalent oral study was conducted with D-002 in New Zealand rabbits and beagle dogs. The LD50 >5000 mg/kg
Dermal
• A reliable (Klimisch 2) guideline equivalent acute dermal study was conducted with icosan-1ol in rabbits. The LD50 >20ml/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986/10/01-1986/11/01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an EU test method and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Lippische Verschs tierzucht HAGEMANN GmbH&Co, D-4923 Extertal 1

- Age at study initiation: 42-50 days

- Weight at study initiation: 156-168g

- Housing: Animals were individually housed in MAKROLON cages

- Diet: Artificial diet for rats ALTROMIN 1324,ad libitum, but discontinued 15-16 hours before administration of dose.

- Water: tap water (ad libitum)




ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21C (+/- 1C)

- Humidity (%): 55% (+/- 5C)

- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: Not stated.
Route of administration:
other: stomach tube
Vehicle:
other: 0.8% hydroxypropyl-methylcellulose gel
Details on oral exposure:
VEHICLE

- vehicle: 0.8% hydroxypropyl-methycellulose gel

- Amount of vehicle (if gavage): 8250 and 1000 mg/kg b.w NACOL 20

Doses:
8250 and 10000 mg/kg
No. of animals per sex per dose:
5 male and 5 female animals were tested for each dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were observed during the 14 day period. The study does not specify how frequently.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All animals were dissected and inspected macroscopically.
Statistics:
No statistical analysis was employed.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
All animals survived the 14 day observation period.
Clinical signs:
No clinical signs of toxicity. There was no adverse effect on food intake.
Body weight:
There was no effect on bodyweight gain.
Gross pathology:
Necropsy findings were unremarkable.
Other findings:
No sex specific differences were apparent and no potential target organs were identified.
No toxic signs in any animals at any dose levels.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 is >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored. Reported in Iuclid 2000.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
mg/kg bw
Quality of whole database:
All experimental animals survived the 14-day test period. There were no clinical signs of toxicity, no body weight gain, and necropsy findings were unremarkable.

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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles, acceptable for assessment. Study considered valid although result reporting is limited.
Qualifier:
no guideline available
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 or test system 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
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw

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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 value of >20ml/kg is reported in a study which even though lacking in detail is deemed reliable and equivalent to guideline.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
mg/kg bw
Quality of whole database:
New Zealand White male rabbits were tested for acute toxicity via the dermal route. After adjusting for density, the LD50 was >20 mL/kg.

Additional information

Olefines polymer, oxidized, hydrolyzed, distillation residues, are by-products of the C20 alcohols manufacturing process. The substance, ‘Olefines polymer, oxidized, hydrolyzed, distillation. residues, are by-products from C20 alcohols manufacturing’, is a UVCB substance that comprises several linear long chain alcohols, predominantly docosan-1-ol (C22), tetracosan-1-ol (C24), hexacosan-1-ol (C26) and eicosan-1-ol (C20). Together, these constituents make up over 80% of the composition ofOlefines polymer, oxidized, hydrolyzed, distillation. residues, are by-products from C20 alcohols manufacturing. Other constituents include, to a much lesser extent, secondary long chain alcohols and complex mixtures of long chain carboxylate esters. On this basis, study data, where available, for each of the long chain alcohol constituents has been evaluated and considered together; this is consistent with the Category approach applied for Long Chain Alcohols (LCA) under REACH. 

 Available data for D-002, a defined mixture of higher aliphatic alcohols (triacontanol, octacosanol, dotriacontrianol, hexacosanol, tetracosanol) isolated from beeswax, has also been considered in this evaluation. In a conservative approach the most sensitive study result from the constituents of the LCA category have been identified and used to address the endpoint in question.

 

Oral

In a reliable (Klimisch 1) OECD 401 GLP compliant study the acute oral toxicity of icosan-1-ol was evaluated. The rat oral LD50 for icosano1-ol was reported as >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored.

In a second reliable key (Klimisch 1) study the acute oral toxicity of docosan-1-ol was assessed. This OECD 423 GLP compliant study reported that no signs of intoxication were found and no remarkable findings on gross necropsy were noted. The LD50 reported in this study was >2000mg/kg.

A third reliable key (Klimisch 2) study analysed D-002 in rabbits and beagles. This guideline equivalent oral study found no significant effects to mortality, clinical signs, body weight or histopatology. The reported LD50 in both animals was >5000 mg/kg

Consequently in line with the read-across justification included, Olefines polymer, oxidized, hydrolyzed, distillation residues, referred to as Nafol 22+, is considered to be of low acute oral toxicity with an LD50 >10g/kg.

 

Dermal

A reliable (Klimisch 2) key study is reported in support of the acute dermal toxicity evaluation of icosan-1-ol. In addition to providing support for the acute dermal endpoint of Olefines polymer, oxidized, hydrolyzed, distillation residues, referred to as Nafol 22+, this data is used to read across to the acute dermal endpoint for docosan-1-ol. In this guideline equivalent study the LD50 was reported to be >20ml/kg. Consequently in line with the read-across justification included, Olefines polymer, oxidized, hydrolyzed, distillation residues, referred to as Nafol 22+, is considered to be of low acute dermal toxicity with an LD50 >20ml/kg

 

Inhalation

Physio-chemical properties of the Olefines polymer, oxidized, hydrolyzed, distillation residues, referred to as Nafol 22+, can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance low volatility with a measured vapour pressure < 0.001 mm Hg at 38°C does not require acute inhalation toxicity testing for this test item.


Justification for selection of acute toxicity – oral endpoint
This reliable Klimish 1 study follows the OECD 401 guidelines and is in compliance with CLP. Male and female Sprague Dawley rats were dosed and followed for 14 days to examine acute effects.

Justification for selection of acute toxicity – dermal endpoint
This reliable Klimish 2 study meets the generally acceptable scientific principles and is acceptable for assessment.

Justification for classification or non-classification

On the basis of read across data, the test substance, Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of C20 alcohols manufacturing, is of low acute toxicity via ingestion (oral LD50 >10g/kg) or via dermal exposure (dermal LD50 >20ml/kg). These findings do not warrant classification of Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of C20 alcohols manufacturing, under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).