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EC number: 217-915-8 | CAS number: 2008-39-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18th June 1998 - 09th July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: no positive control
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)
- Version / remarks:
- Guinea Pig Maximization Test
- Deviations:
- yes
- Remarks:
- , no positive control
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- EC Number:
- 217-915-8
- EC Name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- Cas Number:
- 2008-39-1
- Molecular formula:
- C8H6Cl2O3.C2H7N
- IUPAC Name:
- dimethylammonium 2,4-dichlorophenoxyacetate
- Details on test material:
- - Name of test material (as cited in study report): Aminopielik 600 SL
- Physical state: light brown solution with a characteristic smell
- Analytical purity: 606 g/L active substance expressed as 2,4-D acid
- Impurities (identity and concentrations):
Chlorphenols, expressed as 2,4-dichlorphenol = 0.16%
- Purity test date: 19 May 1998
- Other:
pH = 7.6
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institute of occupational medicine, Lodz, Poland
- Age at study initiation: 3 months (mean)
- Weight at study initiation: males = 658 g (mean), females = 613 g (mean)
- Housing: individually in plast-metalic cages (35 x 30 x 20 cm3)
- Diet: granulated standard food "LSK" ad libitum
- Water: with ascorbic acid ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40 - 80
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- induction: intradermal injection 1% , epicutaneous application 50%
challenge: epicutaneous application 40%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: intradermal injection 1% , epicutaneous application 50%
challenge: epicutaneous application 40%
- No. of animals per dose:
- 8 male and 4 female animals in the treated group,
5 males and 1 female in the control group - Details on study design:
- RANGE FINDING TESTS: Yes (June 1998)
- 4 intradermal injections (1, 2.5, 3, and 5% water solutions of the test substance) of 0.1 mL were administered to the shoulder region of one animal. The skin reaction was observed after 24, 48 and 72 h. A concentration of 1% was chosen for the intradermal injection (induction) as it caused mild-to-moderate skin irritation.
- For the induction and challenge by topical application the concentration of the test substance was established on 4 animals. 30, 40 and 50% water solutions of the test substance were examined. For the induction by topical application the 50% solution was chosen, which caused a mild skin irritation to one animal. For the challenge the 40% solution was chosen, as it was the highest concentration that induced no skin irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: topical induction - 48 h
- Test groups: 1
- Control group: 1 (vehicle control)
- Site: A series of three pairs of intradermal injections of 0.1 mL were given in the shoulder region
- Frequency of applications: Days 0 (injection) and 7 (topical)
- Duration: 21 days
- Concentrations: intradermal induction: 1%, topical induction: 50%
- Other: 24 before topical induction treatment, 0.5 ml of 10% sodium lauryl sulfate in vaseline was applied to the test area of the animals in order to create a local irritation
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction application
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1 (vehicle control)
- Site: left flank
- Concentration: 40%
- Evaluation (hr after challenge): 24, 48 and 72 hours after end of exposure - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40% solution of the test substance
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- discret to moderate erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40% solution of the test substance. No with. + reactions: 1.0. Total no. in groups: 12.0. Clinical observations: discret to moderate erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40% solution of the test substance
- No. with + reactions:
- 5
- Total no. in group:
- 12
- Clinical observations:
- discret to moderate erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40% solution of the test substance. No with. + reactions: 5.0. Total no. in groups: 12.0. Clinical observations: discret to moderate erythema.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 40% solution of the test substance
- No. with + reactions:
- 5
- Total no. in group:
- 12
- Clinical observations:
- discrete erythema
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 40% solution of the test substance. No with. + reactions: 5.0. Total no. in groups: 12.0. Clinical observations: discrete erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no effects observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no effects observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no effects observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no effects observed.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no effects observed
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: water. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no effects observed.
Any other information on results incl. tables
Table 1a: Evaluation of challenge patch test reaction – control
Parameter |
Sex |
Animal No. |
Evaluation after x hours |
|||||
Left flank 40% concentration |
Right flank water |
|||||||
24 |
48 |
72 |
24 |
48 |
72 |
|||
Erythema/ Swelling |
Male |
1 2 3 4 5 |
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 |
female |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 1b: Evaluation of challenge patch test reaction – treated animals
Parameter |
Sex |
Animal No. |
Evaluation after x hours |
|||||
Left flank 40% concentration |
Right flank water |
|||||||
24 |
48 |
72 |
24 |
48 |
72 |
|||
Erythema/ Swelling |
Male |
1 2 3 4 5 6 7 8 |
0 0 0 0 0 0 0 0 |
1 0 1 1 0 0 0 2 |
1 0 1 1 0 0 0 1 |
0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 |
0 0 0 0 0 0 0 0 |
female |
9 10 11 12 |
0 0 0 1 |
0 0 0 1 |
0 0 0 1 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
|
Table 2: Body weight (g)
Group |
Sex |
Animal No. |
Day of the study |
Difference day 1 till day 25 |
|
0 |
25 |
||||
treated |
male |
1 2 3 4 5 6 7 8 |
677 690 667 708 575 551 624 636 |
696 719 751 741 594 582 642 688 |
19 29 84 33 19 31 18 52 |
female |
9 10 11 12 |
546 530 518 534 |
584 591 534 574 |
38 61 16 40 |
|
control |
male |
1 2 3 4 5 |
666 663 781 645 620 |
715 695 781 659 670 |
49 32 0 14 50 |
female |
6 |
695 |
761 |
66 |
|
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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