Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 481-730-0 | CAS number: 848301-65-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
not sensitising (based on results of a reliable OECD 406 study for a related substance, covering the carbon numbers in the range C7-C10)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- , see "Principles of method if other than guideline"
- Principles of method if other than guideline:
- only 10 animals were used in the treatment group (instead of a minimum of 20 animals)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Reliable non-LLNA study / alternative method (Buehler test) was available. Conduction of LLNA study was considered to be scientifically not necessary.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 5 to 6 weeks
- Weight at study initiation: Average body weights at test initiation: 504 to 523 g
- Housing: Individual cages in temperature- and humidity-controlled rooms
- Diet (e.g. ad libitum): continuous access to Purina Certified Guinea Pig Chow f5026
- Water (e.g. ad libitum): ad-libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%): 37 to 58 % R.H.
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Concentrations of test material and vehicle used at each stage of induction:
- Test material: 50% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
Concentrations of test material and vehicle used at each stage of challenge:
- Test material: 25% v/v in paraffin oil
- Vehicle control: paraffin oil undiluted
- Naive control: 25% v/v test material in paraffin oil - No. of animals per dose:
- - test group: 10
- naive control group: 10
- vehicle control group: 10
- positive control group: 20
- naive positive control group: 20 - Details on study design:
- RANGE FINDING TESTS:
A range-finding study consisting of 4 guinea pigs was utilized.
The sample was administered undiluted and at concentrations of 25 %, 50 % and 75 % v/v in paraffin oil
to determine the irritation treshold of the test material.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
3 applications
- Exposure period:
1 application per week, 2 weeks plus two weeks period prior to challenge
- Test groups:
treated group of 10 animals
- Control group:
naive control group of 10 animals, vehicle control group of 10 animals, positive control group of 20 guinea pigs
- Site:
test site on the left anterior quadrant (right anterior quadrant for challenge dose) of each animal
- Frequency of applications:
1 application per week,
- Duration:
6 hours
- Concentrations:
0.4 mL of test material mixture
B. CHALLENGE EXPOSURE
- No. of exposures:
1 application
- Day(s) of challenge:
two weeks after administration of the third sensitising dose, challenge dose was applied.
- Exposure period:
48 hours
- Test groups:
treated group of 10 animals
- Control group:
naive control group of 10 animals, vehicle control group of 10 animals, positive control group of 20 guinea pigs
- Site:
test site on the left anterior quadrant (right anterior quadrant for challenge dose) of each animal
- Concentrations:
0.4 mL of a 25 % v/v mixture of the test material in paraffin oil
- Evaluation (hr after challenge):
24 and 48 hours - Challenge controls:
- At this time, the animals in the naive (previously untreated) control group were also dosed with the test material mixture in the same manner as the test group.
The vehicle control group animals were dosed with 0.4 mL of undiluted paraffin oil. For the positive control group and the previously untreated positive control group the animals were dosed with 0.4 mL of a 0.1 % w/v suspension of 2,4-dinitrochlorobenzene in acetone. - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene
- Positive control substance(s):
- other: 2,4-Dinitrochlorobenzene
- Positive control results:
- Very slight to severe irritation was exhibited by all 20 animals. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive control group
- Dose level:
- 25% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group. Dose level: 25% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- paraffin only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- -
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: -.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0,1% w/v
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema and edema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0,1% w/v. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: very slight erythema and edema.
- Reading:
- other: mean of 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive positive control group
- Dose level:
- 0,1% w/v
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: other: mean of 1st and 2nd reading. . Hours after challenge: 48.0. Group: other: naive positive control group. Dose level: 0,1% w/v. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- - Skin reactions to the induction dose: Slight to moderate erythema and slight edema were observed in the animals dosed with test material.
- Skin reactions to the challenge dose: the test group did not show any skin reaction, like erythema and edema after challange, except 1 out of 10
animals.
Result: It was concluded that, under the conditions of this study, repeated administration of 'Naphtha (petroleum), light alkylate' had a weak potential to cause delayed contact hypersensitivity in guinea pigs. The incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer. - Executive summary:
Young adult guinea pigs (males) were tested for possible sensitisation effects of the test substance 'Naphtha (petroleum), light alkylate' (similar to OECD guideline 406). After 3 consecutive administrations (induction, once per week) a challenge dose was applied. At challenge, a very slight erythema was exhibited by one animal. The other 9 animals had no response. In contrast all 20 of the positive controls responded with reactions ranging from slight to severe irritation. Only one naive control exhibited a very slight erythema upon challenge.
It was concluded that, under the conditions of this study, repeated administration of 'Naphtha (petroleum), light alkylate' had a weak potential to cause delayed contact hypersensitivity in guinea pigs.
The incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer.
Reference
Observations
- Test group: A very slight erthyema reaction was exhibited by one animal. The reaction did not exceed the highest reaction of the naive control animals.The other nine animals exhibited no reaction.
- Naive control group: A very slight erthyema reaction was exhibited by one animal. The other nine animals exhibited no reaction.
- Negative control group: No reaction was exhibited by any animal.
- Positive control group: Very slight to severe irritation was exhibited by all 20 animals. The reactions of 18 animals exceeded the highest reaction observed in the naive positive control animals.
- Naive positive control group: Three of the 20 animals exhibited very slight erythema reactions. The other 17 animals exhibited no reaction.
Other observations:
- All animals appeared normal throughout the study period with the exception of two test animals, five positive control animals, and two naive control animals which exhibited soft stool/diarrhea sporadically throughout the study.
- A slight bodyweight loss of 5 g was recorded during the last week of the study for one test animal. This animal exhibited normal bodyweight gains at all other weighings. Normal body weight gains were recorded for all other animals during the study.
Test Animal: Albino guinea pigs - Hartley strain
Date Animals Received: 12/18/84 and 01/08/85
Date Test Started: 01/02/85
Date Test Completed: 02/28/85
Temperature and Humidity of Animal Room: 21°C to 24°C
37% to 58% relative humidity
Summary of Skin Reactions*
Test Material: Naphtha (petroleum), light alkylate
|
Sensitizing Phase |
Challenge Phase |
||||||
Animal Number |
Three Applications (50% v/v) |
Single Application (25% v/v) |
||||||
Erythema |
Edema |
Erythema |
Edema |
|||||
Average |
(High) |
Average |
(High) |
Average |
(High) |
Average |
(High) |
|
Test Group |
||||||||
E03281 |
0.8 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03282 |
1.3 |
(2) |
0.3 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
E03283 |
0.8 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03284 |
1.3 |
(2) |
0.3 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
E03285 |
1.0 |
(1) |
0.0 |
(0) |
1.0 |
(1) |
0.0 |
(0) |
E03286 |
1.0 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03287 |
0.5 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03288 |
1.3 |
(2) |
0.2 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
E03289 |
0.3 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03290 |
1.0 |
(1) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
|
Challenge Phase |
|||
Animal Number |
Single Application (25% v/v) |
|||
Erythema |
Edema |
|||
Average |
(High) |
Average |
(High) |
|
Naive Control Group |
||||
E03291 |
0.0 |
(0) |
0.0 |
(0) |
E03292 |
0.0 |
(0) |
0.0 |
(0) |
E03293 |
0.5 |
(1) |
0.0 |
(0) |
E03294 |
0.0 |
(0) |
0.0 |
(0) |
E03295 |
0.0 |
(0) |
0.0 |
(0) |
E03296 |
0.0 |
(0) |
0.0 |
(0) |
E03297 |
0.0 |
(0) |
0.0 |
(0) |
E03298 |
0.0 |
(0) |
0.0 |
(0) |
E03299 |
0.0 |
(0) |
0.0 |
(0) |
E03300 |
0.0 |
(0) |
0.0 |
(0) |
*The average erythema and edema value is the mean of the Draize scores for the six observations (sensitizing treatment) or two observations (challenge treatment) of the application site for each animal. The high reading is the largest score recorded for the respective animal during that phase of the study.
|
Sensitizing Phase |
Challenge Phase |
||||||
Animal Number |
Three Applications (Undiluted) |
Single Application (Undiluted) |
||||||
Erythema |
Edema |
Erythema |
Edema |
|||||
Average |
(High) |
Average |
(High) |
Average |
(High) |
Average |
(High) |
|
Vehicle Control Group (Paraffin Oil) |
||||||||
E03301 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03302 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03303 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03304 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03305 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03306 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03307 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03308 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03309 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
E03310 |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
0.0 |
(0) |
|
Sensitizing Phase |
Challenge Phase |
||||||
|
Three Applications (0.3% w/v) |
Single Application (0.1% w/v) |
||||||
Animal |
Erythema |
Edema |
Erythema |
Edema |
||||
Number |
Average |
(High) |
Average |
(High) |
Average |
(High) |
Average |
(High) |
|
Positive Control Group (2,4-dinitrochlorobenzene) |
|||||||
E03371 |
2.0 |
(3) |
1.3 |
(2) |
2.0 |
(2) |
0.0 |
(0) |
E03372 |
1.8 |
(3) |
1.7 |
(3) |
2.0 |
(2) |
0.0 |
(0) |
E03373 |
2.5 |
(3) |
2.0 |
(3) |
1.5 |
(2) |
0.0 |
(0) |
E03374 |
2.3 |
(3) |
1.7 |
(3) |
1.5 |
(2) |
0.0 |
(0) |
E03375 |
3.0 |
(4) |
2.7 |
(4) |
1.5 |
(2) |
0.5 |
(1) |
E03376 |
2.3 |
(3) |
1.3 |
(3) |
2.0 |
(2) |
0.5 |
(1) |
E03377 |
2.8 |
(4) |
1.2 |
(2) |
1.0 |
(1) |
0.0 |
(0) |
E03378 |
2.8 |
(4) |
1.8 |
(3) |
2.0 |
(2) |
0.0 |
(0) |
E03379 |
2.2 |
(3) |
1.3 |
(2) |
2.0 |
(2) |
1.0 |
(1) |
E03380 |
2.2 |
(3) |
1.8 |
(3) |
2.0 |
(2) |
0.5 |
(1) |
E03381 |
2.2 |
(3) |
2.0 |
(3) |
2.0 |
(2) |
0.0 |
(0) |
E03382 |
2.3 |
(3) |
1.8 |
(3) |
1.5 |
(2) |
0.0 |
(0) |
E03383 |
1.7 |
(2) |
0.8 |
(2) |
2.5 |
(3) |
0.5 |
(1) |
E03384 |
2.2 |
(3) |
1.5 |
(2) |
1.0 |
(1) |
0.5 |
(1) |
E03385 |
2.3 |
(3) |
1.5 |
(3) |
1.5 |
(2) |
0.5 |
(1) |
E03386 |
2.2 |
(3) |
1.3 |
(2) |
1.5 |
(2) |
0.0 |
(0) |
E03387 |
2.5 |
(4) |
2.0 |
(4) |
2.0 |
(2) |
1.0 |
(2) |
E03388 |
2.5 |
(4) |
2.0 |
(3) |
1.5 |
(2) |
0.0 |
(0) |
E03389 |
2.2 |
(3) |
1.2 |
(2) |
1.5 |
(2) |
0.5 |
(1) |
E03390 |
2.3 |
(3) |
1.8 |
(3) |
1.5 |
(2) |
0.0 |
(0) |
*The average erythema and edema value is the mean of the Draize scores for the six observations (sensitizing treatment) or two observations (challenge treatment) of the application site for each animal. The high reading is the largest score recorded for the respective animal during that phase of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Young adult guinea pigs (males) were tested for possible sensitisation effects of the test substance 'Naphtha (petroleum), light alkylate' (similar to OECD guideline 406). After 3 consecutive adminstrations (induction, once per week) a challenge dose was applied. At challenge, a very slight erythema was exhibited by one animal. The other 9 animals had no response. In contrast all 20 of the positive controls responded with reactions ranging from slight to severe irritation. Only one naive control exhibited a very slight erythema upon challenge. It was concluded that, under the conditions of this study, repeated administration of 'Naphtha (petroleum), light alkylate', a closely related substance of 'Naphtha (Fischer-tropsch), light, C4-10 - branched and linear', covering the carbon numbers in the range C7-C10, had a weak potential to cause delayed contact hypersensitivity in guinea pigs. The incident of significant response was below the EC trigger threshold for classification as a dermal sensitizer.
Justification for selection of skin sensitisation endpoint:
No sensitisation data are available for the substance defined in section 1. For the endpoint conclusion a reliable study of a related substance with a limited range, (C7-C10) was selected.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data available for non-human and human information.
Justification for classification or non-classification
Based on the available in vivo skin sensitisation data for the related substance 'Naphtha (petroleum), light alkylate' (covering the carbon range C7 -10) , 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' does not require classification as a skin sensitiser according to the criteria of Regulation 1272/2008/EC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.