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EC number: 942-445-1 | CAS number: -
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- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des Produits Chimiques, 15 February 2007
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Acceptable guinea pig maximisation test that followed sound scientific principles
Test material
- Reference substance name:
- NExBTL renewable diesel
- IUPAC Name:
- NExBTL renewable diesel
- Details on test material:
- - Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
- Date received: 04 July 2006
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, F-69592 L'Arbresle, France
- Age at study initiation: approx. 4 wk
- Weight at study initiation: 230 - 278 g
- Housing: group housed
- Diet (e.g. ad libitum): yes (SDS C17.50 guinea pig breeder diet)
- Water (e.g. ad libitum): yes (tap water)
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 45-67
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES
Preliminary studies: 3-4 March 2008
Main study induction: 11 March 2008
Main study challenge: 31 March 2008
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutaneous (occlusive)
- Vehicle:
- other: olive oil (induction), liquid paraffin (challenge)
- Concentration / amount:
- INDUCTION
- intradermal injection (day 0): 25% in olive oil
- epicutaneous application (day 7); 100% (undiluted)
CHALLENGE
- epicutaneous application (day 20); 12.5% and 25% in liquid paraffin
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil (induction), liquid paraffin (challenge)
- Concentration / amount:
- INDUCTION
- intradermal injection (day 0): 25% in olive oil
- epicutaneous application (day 7); 100% (undiluted)
CHALLENGE
- epicutaneous application (day 20); 12.5% and 25% in liquid paraffin
- No. of animals per dose:
- Control: 10
Test: 20 - Details on study design:
- RANGE FINDING TESTS:
MAXIMAL NON-NECROTISING CONCENTRATION (MNNC)
- Objective: to determine concentration of test substance that does not cause severe necrosis after intradermal injection
- No. animals: 2
- Test site: scapular region
- Route: intradermal injection
- Concentration: 100%, 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil
- Evaluation: sites assessed at 24 hr and 48 hr post-injection
PRE-MAXIMAL NON-IRRITANT CONCENTRATION (Pre-MNIC)
- Objective: to assess the irritancy of the test substance toward guinea pig skin, and determine if sodium lauryl sulphate should be used during topical induction phase
- No. animals: 2
- Test site: scapular region
- Route: epicutaneous, under occlusion (see below)
- Concentration: 50%, 25% and 12.5% in liquid paraffin
- Evaluation: sites assessed 24 hr post-application
MAXIMAL NON-IRRITANT CONCENTRATION (MNIC)
- Objective: to determine the maximum concentration of test substance that would be tolerated during topical challenge
- No. animals: 3
- Test site: dorso-lumbar
- Route: epicutaneous, under occlusion (see below)
- Concentration: 25%, 12.5%, 6.25% and 3.125% in liquid paraffin
- Evaluation: sites assessed 24 hr post-application
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL INJECTION
- No. treatments: 1 injection, scapular region, day 0
- Exposure regime: animals received three (3) pairs of intradermal injections (0.1 ml per injection)
- CONTROL GROUP:
- 2 x Freund's Complete Adjuvant/isotonic sodium chloride, 1:1
- 2 x olive oil
- 2 x Freund's Complete Adjuvant/olive oil, 1:1
- TEST GROUP:
- 2 x Freund's Complete Adjuvant/isotonic sodium chloride, 1:1
- 2 x test substance, 25% in olive oil
- 2 x Freund's Complete Adjuvant/test substance, 1:1
B. INDUCTION EXPOSURE - EPICUTANEOUS OCCLUSIVE APPLICATION
- General: fur clipped from scapular region and 10% sodium lauryl sulphate in vaseline applied on day 6
- No. treatments: 1 epicutaneous application, scapular region, day 7
- Exposure regime: single occlusive application (0.5 ml) to region previously subject to i.d. injection
- CONTROL GROUP:
- 100% liquid paraffin
- TEST GROUP:
- 100% test substance
- Exposure period: occlusive wraps removed after 48 hr
C. CHALLENGE EXPOSURE - EPICUTANEOUS OCCLUSIVE APPLICATION
- No. treatments: 1 epicutaneous application, dorso-lumbar region, day 20
- Exposure regime: single occlusive application (0.5 ml)
- CONTROL AND TEST GROUPS:
- 12.5% and 25% test substance in liquid paraffin
- Evaluation (hr after challenge): 24 hr, 48 hr and 72 hr
D. OCCLUSIVE DRESSINGS
- Induction Phase: gauze (Lohmann and Rauscher) held in place with Micropore tape (3M) under Blenderm (3M)
- Challenge Phase: Hayes HA1 chamber, 8mm x 8mm - Challenge controls:
- Challenge controls received 0.5 ml test substance, diluted in liquid paraffin (12.5%; 25%; as above)
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde (aHCA), CAS No 101-86-0
Results and discussion
- Positive control results:
- Clearly positive results obtained with positive control substance:
- 100% sensitisation with 50% aHCA at 24 and 48 hr post-challenge
- 50-100% sensitisation with 25% aHCA at 24 and 48 hr post-challenge
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12.5% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12.5% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- erythema grade 1 in 2 animals; erythema grade 2 in 1 animal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in liquid paraffin. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: erythema grade 1 in 2 animals; erythema grade 2 in 1 animal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- erythema grade 1 in 1 animal
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in liquid paraffin. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: erythema grade 1 in 1 animal.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% in liquid paraffin
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25% in liquid paraffin. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Any other information on results incl. tables
PRELIMINARY STUDIES
MNNC determination:
- slight necrosis following intradermal injection of 100% or 50% test substance in olive oil
- no necrosis at 25% or lower
- 25% was the MNNC and used for intradermal induction in the main test
Pre-MNIC determination:
- slight erythema present 24 hr after exposure to 100% or 50% test substance in liquid paraffin
- no erythema at 25% or lower
- 25% was the Pre-MNIC and used for epicutaneous induction
- 25% selected as the starting point for determination of the MNIC
MNIC determination
- no dermal reactions present at 24 hr
- 25% test substance in liquid paraffin was the MNIC
- 25% and 12.5% were selected as the challenge concentrations
MAIN STUDY
Induction phase:
- Control group
- no cutaneous reactions present after intradermal or epicutaneous treatment
- Test group
- no cutaneous reactions recorded after intradermal induction
- dryness (4/20 animals) and eschar (9/20 animals) present 24 hr after epicutaneous induction.
Challenge phase:
- Control group
- no cutaneous reactions at any time point (24, 48 or 72 hr)
Test group:
- slight or moderate erythema in 3/20 animals at 24 hr post-challenge with 25% test substance
- slight erythema in 1/20 animals at 48 hr post-challenge with 25% test substance
- no dermal responses in any animal 72 hr following challenge with 25% test substance
- no dermal responses in any animal at 24 hr, 48 hr or 72 hr after challenge with 12.5% test substance
WEIGHT GAIN
- negative control animals gained 159.5 g (SD = 30.7) over the course of the study
- test animals gained 150.6 g (SD = 23.4 ) over the same period
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Not a dermal sensitiser.
- Executive summary:
The dermal sensitisation potential of NExBTL renewable diesel was assessed in a GLP-compliant guideline guinea pig maximisation test (skin sensitisation, method B6 of directive 96/54/EC) using 10 control animals and 20 test animals. Based on results of preliminary testing, concentrations of 25% in olive oil (intradermal injection) and 100% (epicutaneous, under occlusion) were administered during the induction phase (study days 0 and 7, respectively) with 12.5% and 25% in liquid paraffin (epicutaneous, under occlusion) used for challenge on study day 20. Dermal responses (erythema, oedema) were recorded at 24, 48 and 72 hr post-challenge. Alpha-hexylcinnamaldehyde (aHCA; n=10 animals) was used as positive control substance. No dermal reactions were present in the negative controls following challenge with NExBTL renewable diesel, however slight or moderate erythema was present in 3/20 animals 24 hr after challenge with 25%, with slight erythema remaining in 1/20 animals at the 48 hr time point. These reactions were fully resolved by 72 hr. No erythema or oedema was in any test animal challenged with 12.5% test substance. A satisfactory response was obtained with the positive control group (100% sensitisation at 50% aHCA; 50-100% with 25%). Both the control (+159.5 g; SD = 30.7) and test groups (150.6 g; SD = 23.4) gained weight over the course of the study. The results demonstrate that NExBTL renewable diesel is not a skin sensitiser.
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