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EC number: 239-784-6 | CAS number: 15687-27-1
- 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
The test substance was not considered to be sensitizing to the 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:
- 1987-05-26 to 1987-06-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was conducted before LLNA test guideline was implemented.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (UKI Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 320 - 398 g
- Housing: groups of up to 4, solid-floor polypropylene cages furnished with softwood shavings
- Diet (ad libitum): Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K.
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): 55-68%
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Route:
- intradermal and epicutaneous
- Vehicle:
- other: arachis oil, Freund's Complete Adjuvant, or no additional vehicle
- Concentration / amount:
- Intradermal Induction : 5% (w/v), i.e. 0.5 % active substance
Topical Induction: undiluted as supplied, i.e. 10 % active substance
Topical Challenge: undiluted as supplied, i.e. 10 % active substance - Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: arachis oil, Freund's Complete Adjuvant, or no additional vehicle
- Concentration / amount:
- Intradermal Induction : 5% (w/v), i.e. 0.5 % active substance
Topical Induction: undiluted as supplied, i.e. 10 % active substance
Topical Challenge: undiluted as supplied, i.e. 10 % active substance - No. of animals per dose:
- 20 test animals
20 control animals - Details on study design:
- 1st application: Induction 0.5 % active substance intracutaneous
2nd application: Induction 10 % active substance occlusive epicutaneous
3rd application: Challenge 10 % active substance semiocclusive
RANGE FINDING TESTS:
Selection of the concentration for intradermal induction:
In a group of four, one animal was applied the test material, Ibuprofen gel 10%, at concentrations of 1, 5, 10, and 25% (w/v) in arachis oil, respectively. Injection sites were read at 24, 48, and 72 h and 78 days after injection.
No evidence of necrosis was observed with 1 and 5%. With 10%, necrosis and eschar formation was noted after 72 h and 7 days, respectively. With 25% necrosis was evident at 24, 48, and 72 h; eschar formation was noted at 7 days. There was no evidence of systemic toxicity in any animal of this group at any time.
According to the authors, based on these result, a concentration of 5% (w/v) was selected for the intradermal induction in the main test.
Selection of the concentration for topical application:
In a group of four, each animal was applied the test material, Ibuprofen gel 10%, both undiluted and as a 75% (w/v) dilution in distilled water (no further information). Skin sites were read at 1, 24, and 48 h after removal of the test patches.
With the undiluted test material, scattered mild redness (Draize score 1) and moderate/diffuse redness (Draize score 2) was observed in 3 and 1 animal(s), respectively at 1 h. With the 75% dilution, scattered mild redness (Draize score 1) was observed in 3 animal, respectively at 1 h. the skin was normal in any animal by 24 h.
According to the authors, based on these result, the undiluted test material (Ibuprofen gel 10% ) was selected for the topical induction and challenge in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
A row of three injections (0.1 ml each) was made an each side of the mid-line. The injections were:
i) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1;
ii) a 5% (w/v) dilution of test material in arachis oil;
iii) a 5% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus arachis oil
Topical:
One week later, the undiluted test material (0.2 - 0.3 ml) was applied on filter paper which was held in place by a strip of surgical adhesive tape and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a strip of elastic adhesive bandage. This occlusive dressing was kept in place for 48 hours.
Erythematous reactions were quantified 1 and 24 h following removal of the patches.
- No. of exposures: single intradermal injection, single topical application
- Exposure period: single intradermal injection, 48-h occluded patch
- Test groups: 5% intradermal, undiluted test material topical
- Control group: concurrent vehicle (intradermal), sham-exposed, i.e. filter paper containing no substance and concurrent coverings (topical)
- Site: neck (intradermal), shoulder (topical)
- Frequency of applications: single (intradermal and topical)
- Duration: 48 h (topical)
- Concentrations: 5% (w/v) intradermal, undiluted (topical)
B. CHALLENGE EXPOSURE
Two weeks after the topical inductions, an area on both flanks of each animal, was clipped free of hair. A quantity of 0.1 - 0.2 ml of the undiluted test material on a filter paper was applied to the shorn right flank. After 24 h, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The position of the treatment sites was identified by using a black indelible marker-pen. After a further 24 and 48 h, any erythematous reactions were quantified and the number of positive responses recorded.
- No. of exposures: single
- Day(s) of challenge: day 21 of the study
- Exposure period: 24 h
- Test groups: undiluted test material
- Site: flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24, 48 h after removal of the patches
OTHER:
Individual body weights of test and control animals were determined at day 0 and day 24.
POSITIVE CONTROL:
A Separate study (Safepharm project No. SF/6) with Formaldehyde, 40% aqueous solution was conducted in March 1987.
Twenty test and ten control animals were used for the study. Following sighting studies the following concentrations of Formaldehyde (40% aqueous solution) were used for the induction and challenge phases.
- intradermal induction: 0.1 % (w/v)
- topical induction (day 7): 50% /w/v)
- topical challenge (day 21): 10% (w/v)
For details, see attached files. - Challenge controls:
- no data
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (40% aqueous solution). Separate study (Safepharm project No. SF/6) conducted in March 1987.
- Positive control results:
- In the test group (Formaldehyde, 40% aqueous solution), skin responses were seen in 19/20 animals after application of the test material and in 0/20 animals after application of the vehicle.
In the control group, skin responses were seen in 0/10 animals after application of the test material and in 0/10 animals after application of the vehicle.
The positive test material Formaldehyde (40% aqueous solution) therefore, produced a 95% (19/20) sensitisation rate and was classified as an extreme sensitiser to guinea pig skin.
For details, see attached file. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
- Executive summary:
Abstract
Test material: IBUPROFEN GEL
1. A study was performed to assess the skin 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.
2. Twenty test and twenty control animals were used for the main study.. Following sighting studies, the following concentrations were used in the induction and challenge phases:
Intradermal Induction : 5'% (w/v)
Topical Induction: undiluted as supplied
Topical Challenge: undiluted as supplied
3. The test material did not produce a sensitisation reaction in any of the twenty test animals, and was classified as a non-sensitiser to guinea pig skin.
Reference
Induction:
Individual reactions were observed at the topical reaction sites of test and control animals.
Transient redness was elicited by ibuprofen gel.
Challenge:
There was no evidence of sensitization response. No skin reactions were observed in the 20 test or 20 control animals.
Body weights:
Body weight gains of guinea pigs in the test group, between day 0 and day 24, were comparable to those observed in the control group
animals over the same period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP-compliant guinea pig maximization study, in accordance with OECD guideline 406, the sensitizing potential of the test substance was evaluated. Twenty animals were intradermal (5% (w/v), i.e. 0.5% active substance) and epicutaneous (undiluted, i.e. 10% active substance) induced with the test substance on day 0 and 7, respectively. The intradermal injections were: A) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with arachis oil in the ratio of 1:1, B) middle row: 2 injections each of 0.1 mL of the test substance formulation, C) back row: 2 injections each of 0.1 mL Freund's adjuvant with arachis oil (1 : 1) with test substance. For the epicutaneous induction the animals were exposed to about 0.1-0.2 mL of the substance for 48 hours. On day 21 the animals were epicutaneously challenged for 24 hours to 100% test substance. Challenge controls were performed in parallel, 20 animals per control group. A positive control was performed with formaldehyde 40% aqueous solution. Both negative and the positive control showed that the results are reliable. Readings were performed 24 and 48 hours after the challenge. No sensitization was observed in all animals. Under the conditions of this test the substance was considered to be not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information classification for skin sensitistation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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