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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 689-188-9 | CAS number: 149343-84-0
- 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
Skin sensitisation
The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
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
- Study period:
- 5 April 1993 to 27 June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The GMPT study is historically available to the registrant as this study was conducted originally for use with the EU NONS scheme. As this study is available and is adequate for classification it is considerd unjustifiable to repeat the animal test to prepare the LLNA study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals (1981), No . 406 "Skin Sensitisation''
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Method B6 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Available study data is +12 years old and is K1 quality.
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Specification
Twenty-one female, albino Dunkin-Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, U.K. At the start of the main study the animals weighed 354 - 445g , and were approximately eight to twelve weeks old. After a minimum acclimatization period of five days, each animal was selected at random and given a number unique within the study which was written on a small area of clipped rump using a black indelible marker-pen.
Husbandry
The animals were housed in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 20 – 24 °C and relative humidity of 44 - 67%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness. - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1% w/v test material
- Day(s)/duration:
- Day 1/7 Days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1% w/v test material in 1:1 Freund's Complete Adjuvant
- Day(s)/duration:
- Day 1/7 Days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Freund;s Complete Adjuvant 1:1 ratio with vehicle
- Day(s)/duration:
- Day 1/7 Days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% w/w
- Day(s)/duration:
- Day 7/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% w/w
- Day(s)/duration:
- Day 21/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- A group of fifteen guinea pigs was used for the main study, ten test and five control.
- Details on study design:
- PROCEDURE
Selection of Concentrations for Main Study (Sighting Tests)
The concentrations of test material to be used at each stage of the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test material. The procedures were as follows:
a) Selection of Concentration for Intradermal Induction
Two animals were intradermally injected with preparations of test material (1% or 5% w/v in distilled water). The highest concentration that did not cause local necrosis, ulceration or systemic toxicity, was selected for the intradermal induction stage of the main study.
b) Selection of Concentration for Topical Induction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant seventeen days earlier) were treated with four preparations of the test material (25%, 10%, 5% and 2% w/w in distilled water).
The highest concentration producing only mild to moderate dermal irritation after a 48-hour occlusive exposure, was selected for the topical induction stage of the main study.
c) Selection of Concentration for Topical Challenge
Two preparations of the test material (25% and 10% w/w in distilled water) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14.
The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
Main Study
A group of fifteen guinea pigs was used for the main study, ten test and five control. The bodyweight of each animal was recorded at the start and end of the study.
Two main procedures were involved in the maximisation test; (a) an induction of a response and (b) a challenge of that response.
a) Induction
Induction of the Test Animals: Shortly before treatment on Day 0 the hair was removed from an area approximately 40 mm x 60 mm on the shoulder region of each animal with veterinary clippers.
A row of three injections (0.1 ml each) was made on each side of the mid-line. The injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 1% (w/v) dilution of test material in distilled water.
iii) a 1% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
Approximately 24 and 48 hours after intradermal injection the degree of erythema at the test material injection sites were evaluated according to the following scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
On day 6, the nuchal region was clipped and shaved. A volume of 0.5 ml of sodium laurylsulphate (10% w/w in petrolatum) was applied in order to provoke an inflammatory response. The treatment sites remained non-occluded.
One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the test material formulation (25% w/w in distilled water). The test material formulation (0.2 - 0.3 ml) was applied on filter paper (WHATMAN No.4: approximate size 40 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 60 mm x 25 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 35 mm) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.
Erythematous reactions were quantified one and twenty-four hours following removal of the patches using the Draize scale from Draize J.H. {1959) Association of Food and Drug Officials of the United States, Austin, Texas, “The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”.
Induction of the Control Animals: Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
i i) distilled water.
iii) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
The topical applications followed the same procedure as for the test animals except that the vehicle alone was applied to the filter paper. Skin reactions were quantified as for the test animals.
b) Challenge
Shortly before treatment on Day 21, an area, approximately 50 mm x 70 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A quantity of 0.1 - 0.2 ml of the test material formulation (25% w/w in distilled water) was applied to the shorn right flank of each animal on a square of filter paper (WHATMAN No.4: approximate size 20 mm x 20 mm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 40 mm x 50 mm). To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 10% (w/w) in distilled water was also similarly applied to a separate skin site on the right shorn flank. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 75 mm) wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt tipped scissors, removed and discarded. The challenge sites were swabbed with cotton wool soaked in distilled water and diethyl ether to remove residual material. The vehicle sites were similarly swabbed. The position of the treatment sites was identified by using a black indelible marker-pen.
Prior to the 24-hour observation the flanks were clipped using veterinary clippers to remove regrown hair.
Evaluation of Skin Reactions
Approximately 24 and 48 hours after challenge dressing removal erythematous reactions were quantified using the Draize scale. - Challenge controls:
- Two preparations of the test material (25% and 10% w/w in distilled water) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14.
The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study. - Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Pale blue-coloured staining was commonly noted at the challenge sites of test and control group animals.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Pale blue-coloured staining was commonly noted at the challenge sites of test and control group animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Pale blue-coloured staining was commonly noted at the challenge sites of test and control group animals
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Pale blue-coloured staining was commonly noted at the challenge sites of test and control group animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% and 10% vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% and 10% vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, JPR BLUE 100, produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.
The test material was also classified as a non-sensitiser according to EEC labelling regulations. No risk phrase is therefore required. - Executive summary:
A study was performed to assess the skin contact sensitisation potential of the test material in the albino guinea pig. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 406 ''Skin Sensitisation" - Magnusson and Kligman Maximisation Test referenced as Method B6 in Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/548/ EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/ EEC (as adapted to technical progress by Commission Directive 91/ 325/ EEC).
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 1% (w/v) in distilled water
Topical Induction: 25% (w/ w) in distilled water
Topical Challenge: 25% and 10% (w/w) in distilled water
The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material was also classified as a non -sensitiser according to EEC labelling regulations. No risk phrase is required.
Reference
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS AT CHALLENGE
CHALLENGE CONCENTRATIONS: 25% AND 10% (w/w) VEHICLE: DISTILLED WATER
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||||||||
24 hours |
48 hours |
|||||||||||
25% |
10% |
Vehicle control |
25% |
10% |
Vehicle control |
|||||||
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
|
1 2 3 4 5 6 7 8 9 10 |
0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA |
0 0 0 0 0 0 0 0 0 0 |
0STA 0STA 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA 0STA |
0 0 0 0 0 0 0 0 0 0 |
0STA 0STA 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
Er = erythema STA = pale blue coloured staining
Oe = oedema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS AT CHALLENGE
CHALLENGE CONCENTRATIONS: 25% AND 10% (w/w) VEHICLE: DISTILLED WATER
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||||||||
24 hours |
48 hours |
|||||||||||
25% |
10% |
Vehicle control |
25% |
10% |
Vehicle control |
|||||||
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
|
11 12 13 14 15 |
0STA 0STA 0STA 0STA 0STA |
0 0 0 0 0 |
0 0 0 0STA 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0STA 0STA 0STA 0STA 0STA |
0 0 0 0 0 |
0 0 0 0STA 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
Er = erythema STA = pale blue coloured staining
Oe = oedema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INTRADERMAL SIGHTING TEST – SUMMARY OF RESULTS
VEHICLE: DISTILLED WATER
Animal Identification |
Time of Observation |
Concentration of Test Material (% w/v) |
Evidence of Local Necrosis |
Evidence of Systemic Toxicity |
A |
24 hours 48 hours 72 hours 7 days |
1 |
None None None None |
None None None None |
B |
24 hours 48 hours 72 hours 7 days |
5 |
Eschar Eschar Eschar Eschar |
None None None None |
The concentration of the test material selected for the intradermal induction stage of the main study was 1% (w/v) in distilled water.
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
TOPICAL SIGHTING TEST FOR INDUCTION APPLICATION
(48-HOUR EXPOSURE) – INDIVIDUAL SKIN REACTIONS
VEHICLE: DISTILLED WATER
Animal Identification |
Concentration of Test Material (% w/w) |
Skin Reactions (Hours After Removal of Patches) |
|||||
1 |
24 |
48 |
|||||
Er |
Oe |
Er |
Oe |
Er |
Oe |
||
C |
25* 10 5 2 |
1STA 1STA 0STA 0STA |
0 0 0 0 |
0STA 0 0 0 |
0 0 0 0 |
0STA 0 0 0 |
0 0 0 0 |
D |
25* 10 5 2 |
1STA 1STA 0STA 0STA |
0 0 0 0 |
0STA 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
* Maximum attainable concentration suitable for topical application.
The concentration of the test material selected for the main study topical induction was 25% (w/w) in distilled water.
Er = erythema STA = slight blue coloured staining
Oe = oedema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
TOPICAL SIGHTING TEST FOR CHALLENGE APPLICATION
(24-HOUR EXPOSURE) – INDIVIDUAL SKIN REACTIONS
VEHICLE: DISTILLED WATER
Animal Identification |
Concentration of Test Material (% w/w) |
Skin Reactions (hours After Removal of Patches) |
|||||
1 |
24 |
48 |
|||||
Er |
Oe |
Er |
Oe |
Er |
Oe |
||
E |
25* 10 |
1STA ?s |
0 0 |
0STA 0STA |
0 0 |
0STA 0STA |
0 0 |
F |
25* 10 |
?s ?s |
0 0 |
0STA 0STA |
0 0 |
0STA 0STA |
0 0 |
* Maximum attainable concentration suitable for topical application
The concentrations of the test material selected for the main study topical challenge were 25% and 10% (w/w) in distilled water
Er = erythema STA = slight blue coloured staining
Oe = oedema ?s = blue coloured staining prevents accurate evaluation of erythema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INTRADERMAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS
INTRADERMAL INDUCTION CONCENTRATION: 1% (w/v) VEHICLE: DISTILLED WATER
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||
24 hours |
48 hours |
|||
Left side |
Right side |
Left side |
Right side |
|
1 2 3 4 5 6 7 8 9 10 |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
?s = blue coloured staining prevents accurate evaluation of erythema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INTRADERMAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS
VEHICLE: DISTILLED WATER
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||
24 hours |
48 hours |
|||
Left side |
Right side |
Left side |
Right side |
|
11 12 13 14 15 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
TOPICAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS
INDUCTION CONCENTRATION: 25% (w/v) VEHICLE: DISTILLED WATER
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||
1 hour |
24 hours |
|||
Er |
Oe |
Er |
Oe |
|
1 2 3 4 5 6 7 8 9 10 |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
0 0 0 0 0 0 0 0 0 0 |
?s ?s ?s ?s ?s ?s ?s ?s ?s ?s |
0 0 0 0 0 0 0 0 0 0 |
Er – erythema ?s = blue coloured staining prevents accurate evaluation of erythema
Oe = oedema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
TOPICAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS
VEHICLE: NOT REQUIRED, BLANK PATCH APPLIED
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||
1 hour |
24 hours |
|||
Er |
Oe |
Er |
Oe |
|
11 12 13 14 15 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
Er – erythema
Oe = oedema
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INDIVIDUAL BODYWEIGHTS AND BODYWEIGHT GAINS OF TEST ANIMALS
Animal Number |
Bodyweight (g) |
Bodyweight (g) Increase |
|
Day 0 |
Day 24 |
||
1 2 3 4 5 6 7 8 9 10 |
411 421 354 403 445 372 441 416 395 444 |
614 585 760 648 606 505 588 646 593 666 |
203 164 406 245 161 133 147 230 198 222 |
JPR BLUE 100: MAGNUSSON & KLIGMAN MAXIMISATION STUDY IN THE GUINEA PIG
INDIVIDUAL BODYWEIGHTS AND BODYWEIGHT GAINS OF CONTROL ANIMALS
Animal Number |
Bodyweight (g) |
Bodyweight (g) Increase |
|
Day 0 |
Day 24 |
||
11 12 13 14 15 |
410 415 386 384 375 |
555 600 593 563 593 |
145 185 207 179 218 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
A study was performed to assess the skin contact sensitisation potential of the test material in the albino guinea pig.
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 1% (w/v) in distilled water
Topical Induction: 25% (w/ w) in distilled water
Topical Challenge: 25% and 10% (w/w) in distilled water
The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
Justification for classification or non-classification
The test material was classified as a non -sensitiser according to EEC labelling regulations. No risk phrase is required.
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.