Registration Dossier

Administrative data

Description of key information

Oral: A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant OECD 425 acute oral toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with alkenes, C11-12, hydroformylation products, distillation. residues. The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats (Kuhn 2010a).
Dermal: A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant OECD 402 semi-occlusive acute dermal toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with alkenes, C11-12, hydroformylation products, distillation. residues. The acute dermal LD50 was greater than 2020 mg/kg bw in male and female rats (Kuhn 2010b).

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:
February - March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is a GLP guideline study and is used in read-across from Alchisor CAL 123 (see 'Read Across Justification Document'). The study merits a Klimisch 1 rating; Klimisch 2 when used for read-across.
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 180 - 210 g
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 25 - 67 (humidity was outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2010-02-16 To: 2010-03-12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.47 mL
Doses:
2000 mg/kg (2.36 mL/kg)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14.
Statistics:
not performed
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
all animals appeared normal for the duration of the study
Body weight:
body weight gain was unaffected by the administration of the test substance
Gross pathology:
no observable abnormalities were seen
Other findings:
none

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

2000

 not tested

 0/5

 0/5

 -

 not tested

 0/5

 0/5

 

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats.
Executive summary:

The test substance, Alkenes, C11 -12, hydroformylation products, distn. residues (CAS No.: 90622 -27 -8), was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. There were no clinical signs of toxicity during the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
February - March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is a GLP guideline study and is used in read-across from Alchisor CAL 123 (see 'Read Across Justification Document'). The study merits a Klimisch 1 rating; Klimisch 2 when used for read-across.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Humidity was outside protocol range but did not affect study outcome.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialities, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 300-336 g (males); 184-200 g (females)
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 25 - 61 (humidity was outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2010-02-10 To: 2010-03-04
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 10
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritation adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritation adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with room temperature tap water and a clean cloth to remove as much residual test substance as possible
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.38 mL/kg
- Constant volume used: no, an individual dose was calculated for each animal based on its day 0 body weight just before exposure
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
2020 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 7 and 14. Observations for evidence of dermal irritation were made at approx. 60 minutes after removal of wrappings and on days 4, 7, 11 and 14.
Statistics:
not performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
no clinical signs of toxicity or dermal irritation were recorded
Body weight:
animals exhibited weekly weight gain during the study
Gross pathology:
no observable abnormalities were detected
Other findings:
none
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was greater than 2020 mg/kg bodyweight in male and female rats.
Executive summary:

The test substance, Alkenes, C11 -12, hydroformylation products, distn. Residues (CAS No. 90622 -27 -8), was evaluated for its dermal toxicity potential and relative skin irritancy when a single undiluted dose of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There were no clinical signs of toxicity of signs of dermal irritation at any time throughout the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 020 mg/kg bw

Additional information

Alchisor CAL 145 comprises alkenes C13-14 hydroformylation products with read-across from the chemically-similar Alchisor CAL 123 as defined in the `Read-Across Justification Document'. Where toxicological data exist for Alchisor CAL 123, these are representative of the Alchisor CAL 145 substance.

Oral

A reliable (Klimisch 1; Klimisch 2 when used for read-across) GLP compliant OECD 425 acute oral toxicity (Up-and-Down Procedure) study was conducted in Sprague-Dawley rats (5/sex/dose). The test item in this study was alkenes, C11-12, hydroformylation products, distillation. residues (CAS No. 90622 -27 -8, commercial name: Alchisor CAL). No mortality occurred during the study. There were no clinical signs of toxicity during the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

 

Dermal

The test substance, alkenes, C11 -12, hydroformylation products, distn. residues (CAS No. 90622 -27 -8), was evaluated for its dermal toxicity potential and relative skin irritancy when a single undiluted dose of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There were no clinical signs of toxicity of signs of dermal irritation at any time throughout the study. Animals exhibited weekly weight gain during the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.

 

Inhalation

Physico-chemical properties of alkenes, C11 -12, hydroformylation products, distillation. residues can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance alkenes, C11 -12, hydroformylation products, distillation. residues is of low volatility with a measured vapour pressure <0.5 pa. Consequently acute inhalation toxicity testing for this test item is not required.

Justification for classification or non-classification

The test substance, alkenes, C11-12, hydroformylation products, distillation. residues is of low acute toxicity via ingestion (oral LD50 >2000mg/kg bw) or via dermal exposure (dermal LD50 >2020mg/kg bw). These findings do not warrant classification of alkenes, C11-12, hydroformylation products, distillation. residues under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).