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EC number: 202-675-9 | CAS number: 98-51-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-02-02 to 1988-02-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The selected method was the maximization test of Magnusson-Kligman (1969). J Invest Dermatol 52: 268-276.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- 4-tert-butyltoluene
- EC Number:
- 202-675-9
- EC Name:
- 4-tert-butyltoluene
- Cas Number:
- 98-51-1
- Molecular formula:
- C11H16
- IUPAC Name:
- 1-tert-butyl-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): p-tert-butyltoluene
- Physical state: colourless liquid
- Analytical purity: 99.53%
- Impurities (identity and concentrations): no data
- Lot/batch No.: 2339/8608; date of manufacture: 1986-08-12
No further data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
female albino guinea pigs, Bor:DHPW
- Source: F. Winkelmann, D-4799 Borchen; Germany
- Age at study initiation: no data
- Weight at study initiation: mean body weights: 330.1 g (experimental group); 330.9 g (control group)
- Housing: 1 - 5 animals in Type IV Makrolon cages
- Diet (ad libitum): feed for guinea pigs, Ssniff Spezialfutter GmbH, D-4770 Soest
- Water (ad libitum): tap water
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 55 - 65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant (FCA), maize germ oil, water
- Concentration / amount:
- 20% (intracutaneous induction);
undiluted (epicutaneous induction);
50% (challenge)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Freund's Complete Adjuvant (FCA), maize germ oil, water
- Concentration / amount:
- 20% (intracutaneous induction);
undiluted (epicutaneous induction);
50% (challenge)
- No. of animals per dose:
- 20 females (test group);
10 females (control group) - Details on study design:
- RANGE FINDING TESTS:
no data
MAIN STUDY
A. INDUCTION EXPOSURE
1. intracutaneous induction
A 4 x 6 cm area of skin on both shoulders is carefully shaved. 2 to 3 hours later, a total of 6 intracutaneous injections are administered symmetrically and simultaneously as follows, each on the right and left:
- 0.1 ml Freund's Complete Adjuvant (FCA) and water in the ratio 1 : 1
- 0.1 ml of test product 20 % in maize germ oil
- 0.1 ml of test product 20 % in a mixture of FCA and maize germ oil in the ratio 1 : 1.
The control animals receive the same number of intracutaneous injections in the same area of the back as follows:
- 0.1 ml of a mixture of FCA and water in the ratio 1 : 1
- 0 .1 ml maize germ oil
- 0.1 ml of a mixture of FCA and maize germ oil in the ratio 1 : 1.
2. epicutaneous induction
One week after the intracutaneous injections the patch test is carried out. The skin over the injection area is shaved, and 2 to 3 hours later, a 2 x 4 cm filter paper, impregnated with the undiluted test substance, is placed thereon and covered with a 6 x 6 cm adhesive tape (Leukoflex). The patch 40 is immobilised for 48 hours with an elastic dressing. The control animals receive a patch containing maize germ oil.
B. CHALLENGE EXPOSURE
The challenge exposure is effected two weeks later. The left flank of the guinea pigs is shaved. 2 to 3 hours later, a 2 x 2 cm filter paper is impregnated with the test substance 50 % in maize germ oil for each animal and placed on the left front flank. The patch is covered with a 6 x 6 cm adhesive tape (Leukoflex) and immobilised for 24 hours with an elastic dressing.
The control animals receive the same treatment.
The reaction is assessed 24 and 48 hours after removal of the elastic dressing. If necessary the skin is shaved 2 - 3 hours beforehand.
The reactions are evaluated in accordance with the following scheme:
No erythema: 0
Slight erythema: 1
Distinct and diffuse erythema: 2
Severe erythema and edema: 3
OTHER:
The animals were weighed before the start of the experiment and then once a week. - Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- 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: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Sensitisation reactions:
Skin reactions were seen in 0/20 test animals and in 0/10 control animals at both the 24- and 48-hour reading.
General observations:
There were no general reactions during the investigation, and the treatment had no serious influence on the increase in body weight.
Local reactions were limited to irritation at the sites treated with FCA by intracutaneous injection and topical application; erythema, edema, slight necrosis, and eschar formation were recorded in both test and control animals.
At the sites treated with maize germ oil, slight erythema and edema was noted at the injection sites.
For details, see attached files.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In the maximization test of Magnusson-Kligman, p-tert.-butyltoluene showed no sensitising effect on the skin of female guinea pigs.
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