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EC number: 437-450-6 | CAS number: -
- 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
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- Additional physico-chemical information
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- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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 25% (5/20) sensitisation rate and was classified as a mild sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations.
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:
- 10 May 1999 to 27 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Method B6 of Commission Directive 96/54/EC (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:
- Study data available from study performed in 1999.
- Specific details on test material used for the study:
- No further details specified in the study report.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Forty male albino Dunkin Hartley guinea pigs supplied by David Hall Limited, Burton-on-Trent, Staffordshire, UK were used. At the start of the main study the animals weighed 352 to 4468, and were approximately eight to twelve weeks old. After an acclimatisation period of at least 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 markerpen.
The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness. - Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- 25% w/v
- Day(s)/duration:
- 21
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- 2
- No. of animals per dose:
- A group of thirty guinea pigs was used for the main study, twenty test and ten control.
- Details on study design:
- 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:
Selection of Concentration for lntradermal Induction
Four concentrations of test material were investigated (1 %, 5%, 10% and 25% w/v in arachis oil BP). A total of four guinea pigs were used, each guinea pig receiving four 0.1 ml injections of only one concentration of test material. The degree of erythema at the injection sites was assessed approximately 24, 48 and 72 hours and 7 days after injection. The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
Selection of Concentration for Topical lnduction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant ten days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil BP). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 48 hours. The degree of erythema and oedema was evaluated approximately
1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
Selection of Concentration for Topical Challenge
The undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil BP) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. These guinea pigs had been intradermally injected with Freund's Complete Adjuvant ten days earlier. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. 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 thirty guinea pigs was used for the main study, twenty test and ten control. The bodyweight of each animal was recorded at the start and end of the study.
Two main phases were involved in the main study; (a) an induction of a response and (b) a challenge of that response.
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:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1 :1
b) a 25% w/v formulation of the test material in arachis oil BP
C) a 25% w/v formulation of the 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 (ie. Injection site b) was evaluated.
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 undiluted test material. A filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), saturated with the undiluted test material was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil. The patch and foil were further secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
This occlusive dressing was kept in place for 48 hours.
The degree of erythema and oedema was quantified one and twenty four hours following removal of the patches.
Any other reactions were also recorded.
Induction of the Control Animals: lntradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil BP
C) 50% w/v formulation of arachis oil BP in a 1:1 mixture of Freund's Complete Adjuvant/distilled water
Approximately 24 and 48 hours after intradermal injection the degree of erythema at the vehicle injection sites (ie injection site b) was evaluated.
The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals.
Challenge
Shortly before treatment on Day 21, an area of approximately 50 mm x 70 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A square filter paper patch (WHATMAN No.4: approximate size 20 mm x 20 mm), saturated with the undiluted test material was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% v/v in arachis oil BP was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage 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 diethyl ether to remove residual material. 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, the degree of erythema and oedema was quantified.
Any other reactions were also recorded. - Challenge controls:
- Not specified
- Positive control substance(s):
- yes
- Remarks:
- historical control data
- Positive control results:
- Reported in table form - See "Any other information" for details.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% v/v
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% & 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% & 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: Positive control data for the Magnusson & Kligman Maximisation study in the guinea pig were based on laboratory historical control data for the strain tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, APAN, produced a 25% (5/20) sensitisation rate and was classified as a MILD SENSlTlSER to guinea pig skin. The test material did not meet the criteria
for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required. - Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 96/54/EC (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 93/21/EEC).
Twenty test and ten 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: 25% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: undiluted as supplied and 75% v/v in arachis oil BP
The test material produced a 25% (5/20) sensitisation rate and was classified as a mild sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.
Reference
INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS AT CHALLENGE
CHALLENGE CONCENTRATIONS: UNDILUTED AS SUPPLIED AND 75% v/v VEHICLE: ARACHIS OIL BP
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||||||||
24 Hours |
48 Hours |
|||||||||||
100% |
75% |
100% |
75% |
|||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
|
1 |
2 |
1 |
- |
1 |
0 |
- |
1 |
1 |
- |
0 |
0 |
- |
2 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
3 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
4 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
5 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
6 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
7 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
8 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
9 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
10 |
1 |
1 |
- |
1 |
1 |
- |
1 |
0 |
- |
1 |
0 |
- |
11 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
12 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
13 |
1 |
0 |
- |
2 |
1 |
- |
1 |
0 |
- |
1 |
1 |
- |
14 |
2 |
1 |
- |
0 |
0 |
- |
1 |
0 |
- |
0 |
0 |
- |
15 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
16 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
17 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
18 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
19 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
20 |
1 |
0 |
- |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Er = erythema Oe = oedema - = no other reactions noted
INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS AT CHALLENGE
CHALLENGE CONCENTRATIONS: UNDILUTED AS SUPPLIED AND 75% v/v VEHICLE: ARACHIS OIL BP
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||||||||
24 Hours |
48 Hours |
|||||||||||
100% |
75% |
100% |
75% |
|||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
|
21 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
22 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
23 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
24 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
25 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
26 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
27 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
28 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
29 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
30 |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Er = erythema Oe = oedema - = no other reactions noted
INTRADERMAL SIGHTING TEST – SUMMARY OF RESULTS
VEHICLE: ARACHIS OIL BP
Animal Identification |
Time of Observation |
Concentration of Test Material (% w/v) |
Grade of Erythema at Injection Sites |
Evidence of Systemic Toxicity |
A |
24 Hours 48 Hours 72 Hours 7 Days |
1 |
1 1 1 1 |
None None None None |
B |
24 Hours 48 Hours 72 Hours 7 Days |
5 |
2 2 2 1 |
None None None None |
C |
24 Hours 48 Hours 72 Hours 7 Days |
10 |
2 2 2 2 |
None None None None |
D |
24 Hours 48 Hours 72 Hours 7 Days |
25 |
2 2 2 2 |
None None None None |
The concentration of the test material selected for the intradermal induction stage of the main study was 25% w/v in arachis oil BP.
TOPICAL SIGHTING TEST FOR INDUCTION APPLICATION (48-HOUR EXPOSURE) – INDIVIDUAL SKIN REACTIONS
VEHICLE: ARACHIS OIL BP
Animal Identification |
Concentration of Test Material (% v/v) |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
||
E |
100 75 50 25 |
1 2 1 1 |
0 0 0 0 |
- - - - |
1 1 1 1 |
0 0 0 0 |
- - - - |
1 1 1 1 |
0 0 0 0 |
- - - - |
F |
100 75 50 25 |
2 2 2 2 |
0 0 0 0 |
- - - - |
1 1 1 1 |
0 0 0 0 |
- - - - |
1 1 1 1 |
0 0 0 0 |
- - - - |
Er = erythema Oe = oedema - = no other reactions noted
The undiluted test material was selected for the main study topical induction
TOPICAL SIGHTING TEST FOR CHALLENGE APPLICATION (24-HOUR EXPOSURE) – INDIVIDUAL SKIN REACTIONS
VEHICLE: ARACHIS OIL BP
Animal Identification |
Concentration of Test Material (% v/v) |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
Er |
Oe |
Other |
Er |
Oe |
Other |
Er |
Oe |
Other |
||
I |
100 75 50 25 |
1 1 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
J |
100 75 50 25 |
2 1 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
Er = erythema Oe = oedema - = no other reactions noted
The concentrations of the test material selected for the main study topical challenge were undiluted as supplied and 75% v/v in arachis oil BP
INTRADERMAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS
INDUCTION CONCENTRATION: 25% w/v VEHICLE: ARACHIS OIL BP
Animal Number |
Grade of Erythema at Observation Time |
|||
24 Hours |
48 Hours |
|||
Left Side |
Right Side |
Left Side |
Right Side |
|
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 |
2 2 2 2 2 2 2 2 2 2 1 2 2 1 2 2 2 2 2 2 |
2 2 2 2 2 2 2 2 2 2 1 2 2 1 2 2 2 2 2 2 |
2 2 2 2 2 2 2 2 2 2 1 1 2 1 2 2 2 2 2 2 |
2 2 2 2 2 2 2 2 2 2 1 1 2 1 2 2 2 2 2 2 |
INTRADERMAL INDUCTION – INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS
VEHICLE: ARACHIS OIL BP
Animal Number |
Grade of Erythema at Observation Time |
|||
24 Hours |
48 Hours |
|||
Left Side |
Right Side |
Left Side |
Right Side |
|
21 22 23 24 25 26 27 28 29 30 |
1 1 1 1 1 1 1 1 1 1 |
1 1 1 1 1 1 1 1 1 1 |
1 1 1 1 1 1 1 1 1 1 |
1 1 1 1 1 1 1 1 1 1 |
TOPICAL INDUCTIONS – INDIVIDUAL SKIN REACTIONS IN TEST ANIMALS
INDUCTION CONCENTRATION: UNDILUTED AS SUPPLIED
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||
1 Hour |
24 Hours |
|||||
Er |
Oe |
Other |
Er |
Oe |
Other |
|
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 |
2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 |
0 0 0 0 1 0 1 0 1 1 1 0 1 1 0 0 0 1 1 1 |
Bs Bs - - - - - Bs Bs Bs Bs Bs Bs Bs - - Bs Bs Bs Bs |
1 1 2 1 2 2 1 1 1 2 2 2 1 2 2 2 2 1 2 2 |
0 0 0 0 0 0 0 0 1 1 2 1 1 2 1 0 1 0 2 1 |
- - - - - - - - - - - - - - - - - - - - |
Er = erythema Oe = oedema
Bs = bleeding from intradermal injection site - = no other reactions noted
TOPICAL INDUCTIONS – INDIVIDUAL SKIN REACTIONS IN CONTROL ANIMALS
VEHICLE: BLANK PATCH APPLIED
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||
1 Hour |
24 Hours |
|||||
Er |
Oe |
Other |
Er |
Oe |
Other |
|
21 22 23 24 25 26 27 28 29 30 |
0 0 0 1 0 1 1 1 1 0 |
0 0 0 0 0 0 0 0 0 0 |
Bs Bs Bs Bs Bs - Bs Bs Bs Bs |
0 0 0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 0 0 |
- - - - - - - - - - |
Er = erythema Oe = oedema
Bs = bleeding from intradermal injection site - = no other reactions noted
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 11 12 13 14 15 16 17 18 19 20 |
386 412 380 352 373 384 377 403 389 378 381 431 432 430 413 364 439 385 373 384 |
613 622 557 554 568 565 621 631 652 602 588 693 730 645 633 594 660 600 598 636 |
227 210 177 202 195 181 244 228 263 224 207 262 298 215 220 230 221 215 225 252 |
INDIVIDUAL BODYWEIGHTS AND BODYWEIGHT GAINS OF CONTROL ANIMALS
Animal Number |
Bodyweight (g) |
Bodyweight (g) Increase |
|
Day 0 |
Day 24 |
||
21 22 23 24 25 26 27 28 29 30 |
384 429 379 446 405 399 434 406 372 394 |
611 657 637 660 630 646 630 669 626 594 |
227 228 258 214 225 247 196 263 254 200 |
SUMMARY OF POSITIVE CONTROL DATA FOR THE MAGNUSSON AND KLIGMAN MAXIMISATION STUDY
Project Number |
Date Start |
Date End |
Number of Animals and Sex* |
Positive Control Material |
Concentration |
Incidence of Sensitisation |
|||
Induction |
Challenge |
||||||||
Test |
Control |
Intradermal |
Topical |
||||||
039/239 |
11/11/96 |
06/12/96 |
10 Female |
5 Female |
2-Mercaptobenzothiazole |
10% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
90% (9/10) |
039/249 |
22/05/97 |
15/06/97 |
10 Female |
5 Female |
2-Mercaptobenzothiazole |
10% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
70% (7/10) |
039/258 |
17/10/97 |
10/11/97 |
10 Female |
5 Female |
2-Mercaptobenzothiazole |
10% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
90% (9/10) |
039/284 |
11/05/98 |
04/06/98 |
10 Male |
5 Male |
2-Mercaptobenzothiazole |
10% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
100% (10/10) |
039/333 |
22/12/98 |
05/02/99 |
10 Female |
5 Female |
2-Mercaptobenzothiazole |
10% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
90% (9/10) |
039/370 |
14/06/99 |
17/07/99 |
10 Male |
5 Male |
2-Mercaptobenzothiazole |
5% in arachis oil BP |
50% in acetone: PEG 400 (70:30) |
50% and 25% in acetone: PEG 400 (70:30) |
100% (10/10) |
* All animals supplied by David Hall Ltd.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
Twenty test and ten 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: 25% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Topical Challenge: undiluted as supplied and 75% v/v in arachis oil BP
The test material produced a 25% (5/20) sensitisation rate and was classified as a mild sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations.
Justification for classification or non-classification
Skin sensitisation
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 93/21/EEC).
The test material produced a 25% (5/20) sensitisation rate and was classified as a mild sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.
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