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EC number: 905-276-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Water solubility
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,4 xylenol
- IUPAC Name:
- 2,4 xylenol
- Reference substance name:
- 2,4 dimethylphenol
- IUPAC Name:
- 2,4 dimethylphenol
- Details on test material:
- - Name of test material (as cited in study report): 2,4 xylenol
- Physical state: Liquid (yellowish)
- Analytical purity: 99.5% (99.5g/100g)
- Impurities (identity and concentrations): Not stated
- Purity test date:Not stated
- Lot/batch No. 14822 JF
- Stability under test conditions: Not stated
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Lutrol E 400 DAB
- Concentration / amount:
- Intradermal inducton: 0.5% test substance in Lutrol E 400 DAB
Percutaneous induction: 25% test substance in Lutrol E 400 DAB
1st and 2nd Challenge: 5% Test substance in Lutrol E 400 DAB
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Lutrol E 400 DAB
- Concentration / amount:
- Intradermal inducton: 0.5% test substance in Lutrol E 400 DAB
Percutaneous induction: 25% test substance in Lutrol E 400 DAB
1st and 2nd Challenge: 5% Test substance in Lutrol E 400 DAB
- No. of animals per dose:
- 20 animals/test group
10 animals/control group - 2 control groups
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: 1st and 2nd control groups
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 1st and 2nd control groups. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 1st and 2nd control groups
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: 1st and 2nd control groups. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: 1st and 2nd control groups
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 1st and 2nd control groups. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: 1st control group
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: 1st control group. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy eythema; moderate and confluent erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy eythema; moderate and confluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythem; moderate and confluent erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythem; moderate and confluent erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: 1st and 2nd control groups
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: 1st and 2nd control groups. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: 1st and 2nd control groups
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 1st and 2nd control groups. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema; moderate and confluent erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema; moderate and confluent erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Test substance 5% in Lutrol E 400 DAB
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: Test substance 5% in Lutrol E 400 DAB. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Lutrol E 400 DAB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: Lutrol E 400 DAB. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Results:
Intradermal induction, moderate and copnfluent erythema and swelling were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant in NaCl was applied. Necrotic changes and swelling were observed in the other sites (lutrol E 400 DAB and 50% Lutrol with FCA / 0.9% NaCl(aq)).
Injections with 0.5% test substance in Lutrol E 400 DAB also caused swelling and necrotic skin changes. Moderate and confluent erythema and swelling were observed at the injection sites of all test group animals which were applied with a 0.5% test test substance preparation in FCA/0.9% NaCl (aq).
Percutaneous induction (1 week later): Controls treated with Lutrol E 400 (no reaction). Induction with 2,4 xylenol (25% in Lutrol E 400 DAB) gave rise to swelling and necrotic skin changes.
1st challenge (14 days later): No findings in all control animals at 24 or 48hrs.
Test animals 24hrs: 1/20 intense erythema and swelling; 8/20 moderate and confluent erythema; 2/20 discrete or patchy erythema.
Test animals 48hrs: 4/20 moderate and confluent erythema; 3/20 discrete or patchy erythema.2/20 dscrete or patchy erythema as well as scaling
2nd challenge (1 week later): No findings in all control animals at 24 or 48hrs.
Test animals 24hrs: 4/20 moderate and confluent erythema; 3/20 discrete or patchy erythema.
Test animals 48hrs: 1/20 moderate and confluent erythema; 5/20 discrete or patchy erythema
Challenge and rechallenge results presented above.
Table 1: 1st Control group - intradermal induction:
Form of application A. Freund’s adjuvant / 0.9% NaCl (aq) 1:1 B Lutrol E 400 DAB C 50% preparation of Lutrol E 400 DAB with Freund’s adjuvant / 0.9% NaCl (aq) 1:1 |
|||||||||||||||||||||
Animal |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
|||||||||||
24hr |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
|
|
A |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
B |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
|
C |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Table 2: 2nd Control group - intradermal indcution:
Form of application A. Freund’s adjuvant / 0.9% NaCl (aq) 1:1 B Lutrol E 400 DAB C 50% preparation of Lutrol E 400 DAB with Freund’s adjuvant / 0.9% NaCl (aq) 1:1 |
|||||||||||||||||||||
Animal |
21 |
22 |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
|||||||||||
24hr |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
|
|
A |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
B |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
|
C |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Table 3: Test group - intradermal induction:
Form of application A. Freund’s adjuvant / 0.9% NaCl (aq) 1:1 B Test substance 0.5% in Lutrol E 400 DAB C Test substance 0.5% in Freund’s adjuvant / 0.9% NaCl (aq) 1:1 |
|||||||||||||||||||||
Animal |
31 |
32 |
33 |
34 |
35 |
36 |
37 |
38 |
39 |
40 |
|||||||||||
24hr |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
|
|
A |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
B |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
|
C |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
Form of application A. Freund’s adjuvant / 0.9% NaCl (aq) 1:1 B Test substance 0.5% in Lutrol E 400 DAB C Test substance 0.5% in Freund’s adjuvant / 0.9% NaCl (aq) 1:1 |
|||||||||||||||||||||
Animal |
41 |
42 |
43 |
44 |
45 |
46 |
47 |
48 |
49 |
50 |
|||||||||||
24hr |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
R |
L |
|
|
A |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
B |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
|
C |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
2E |
R = right
L = left
2 = Moderate and confluent erythema
E = swelling
N = necrotic skin changes
Table 4: 1st Control group - percutaneous induction
Form of application: Lutrol E 400 DAB
|
||||||||||
Animal |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
48hr |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Table 5: 2nd Control group - percutaneous induction
Form of application: Lutrol E 400 DAB
|
||||||||||
Animal |
21 |
22 |
23 |
24 |
25 |
26 |
27 |
28 |
29 |
30 |
48hr |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Table 6: Test group - percutaneous induction
Form of application: Test substance 25% in Lutrol E 400 DAB
|
||||||||||
Animal |
31 |
32 |
33 |
34 |
35 |
36 |
37 |
38 |
39 |
40 |
48hr |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Form of application: Test substance 25% in Lutrol E 400 DAB
|
||||||||||
Animal |
41 |
42 |
43 |
44 |
45 |
46 |
47 |
48 |
49 |
50 |
48hr |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
NE |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- A clear sensitising effect was observed for 2,4 xylenol when investigated in guinea pigs in the Maximisation test.
- Executive summary:
In a dermal sensitization study, guinea pigs (20/sex) received intradermal injections of 0.5% 2,4 xylenol (administered in Lutrol E 400 DAB and Freund’s Complete Adjuvant (FCA)) / 0.9% NaCl (1:1)). The treatment regime involved induction of sensitization by intradermal injection on day 1, induction of sensitization by topical administration one week later (25% 2,4 xylenol in Lutrol E 400 DAB), challenge by topical administration on day 21 (5% 2,4 xylenol in Lutrol E 400 DAB), followed by a rechallenge on day 28 (5% 2,4 xylenol in Lutrol E 400 DAB).
Following intradermal induction, 0.5% 2,4 xylenol caused swelling and moderate erythema. One week laterm percutaneous induction with 25% 2,4 xylenol in Lutrol E 400 DAB resulted in swelling and necrotic changes. Following challenge, 11/20 test animals test animals showed a positive allergic reaction. Following rechallenge 8/20 test animals showed a positive allergic reaction. The 5% 2,4 xylenol applied to control animals was tolerated and no skin reactions were observed in the control groups.
2,4 xylenol showed a clear skin sensitisation potential in this study.
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