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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin Irritation/Corrosion
The key study for skin irritation/corrosion was a reliable (Klimisch 1) OECD 404 study with docosan-1-ol. In this study docosan-1-ol was considered not to be a skin irritant when applied to rabbit skin.
Eye Irritation
The key study for eye irritation was a reliable (Klimisch 1) OECD 405 study with docosan-1-ol. In this study docosan-1-ol was considered not to be an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
18/06/1997-21/06/1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to current OECD guideline and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.81 - 3.15 kg
- Housing:individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: mains water, ad libitum
- Acclimation period:minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 59-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5ml distilled water



Duration of treatment / exposure:
4 hour(s)
Observation period:
Ca. 1h, 24h, 48h, 72h after patch removal
Number of animals:
3F
Details on study design:
TEST SITE
- Area of exposure: shorn dorsal  surface of the skin,  2.5 x 2.5 cm
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape, wrapped in an elastic corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h


SCORING SYSTEM: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritant / corrosive response data:
The test material produced a primary irritation index of 0.0. 
Other effects:
No evidence of skin irritation was noted during the study other than very slight  erythema at one test site at 1 hour after patch removal. All other scores  were 0.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol 220-80 is not a skin irritant when applied to rabbit skin undiluted in a 4 hour semi-occlusive exposure. Group mean 24+48+72 hours were 0.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.80-2.90kg
- Housing: individually suspended metal cages.
- Diet: Stanrab SQC Rabbit diets, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 58-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12


Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
Amount applied: 0.1 ml (ca. 62mg)
Duration of treatment / exposure:
single instillation, not rinsed
Observation period (in vivo):
Assessment of ocular damage was made approximately 1h, 24h, 48h and 72h following treatment.
Number of animals or in vitro replicates:
1F, 2M
Details on study design:
Comment: not rinsed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72h
Score:
10.7
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.1
Max. score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.53
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
Moderate conjunctival irritation was reported in  all animals one  hour after treatment with minimal to moderate  conjunctival irritation at the 24 hour observation time. At 48 hours minimal conjunctival redness was observed in one animal only. All scores were 0 at 72 hours.
Other effects:
None reported.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol is not classifiable as an eye irritant according to EU or GHS criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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.  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

 

Skin Irritation/Corrosion

A reliable (Klimisch 1) OECD 404 study was conducted with docosan-1-ol. Rabbits were treated with undiluted docosan-1-ol in a 4 hour semi-occlusive exposure. No evidence of skin irritation was noted during the study  other than very slight  erythema at one test site at 1 hour after patch removal. All other scores were 0. Docoson-1-ol was considered not irritating to rabbit skin. Consequently in line with the read-across justification included, Olefines polymer, oxidized, hydrolyzed, distillation residues, referred to as Nafol 22+, is considered to be non-irritating.

Eye Irritation

A reliable (Klimisch 1) OECD 405 was conducted with docosan-1-ol. Moderate conjunctival  irritation was  reported in all animals one hour after treatment with  minimal to moderate  conjunctival  irritation at  the 24 hour observation time. At 48 hours minimal conjunctival redness was observed in one animal only. All scores were 0 at 72 hours. Docoson-1-ol was considered not irritating to the rabbit eye. Consequently in line with the read-across justification included, Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of C20 alcohols manufacturing, is considered to be non-irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
This was a reliable Klimish 1 study that followed the OECD 404 guidelines and was GLP compliant. Female New Zealand White rabbits were exposed to 4 hours of semiocclusive treatment with docosan-1-ol. All rabbits had a PMII score of 0.

Justification for selection of eye irritation endpoint:
This was a reliable Klimish 1 study that followed the OECD 404 guidelines and was GLP compliant. Male and female New Zealand White rabbits were exposed to docosan-1-ol. Moderate conjunctival irritation was reported in  all animals one  hour after treatment, but all scores were 0 at 72 hours.

Justification for classification or non-classification

These findings do not warrant the classification of Olefines polymer, oxidized, hydrolyzed, distillation residues, a by-product of alcohols manufacturing, as skin or ocular irritants under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.