Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 407-410-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-01-29 to 1991-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to outdated OECD Guideline 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed prior to availability of LLNA methodology.
Test material
- Reference substance name:
- 4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
- EC Number:
- 407-410-2
- EC Name:
- 4,7-methanooctahydro-1H-indene-diyldimethyl bis(2-carboxybenzoate)
- Molecular formula:
- C28H40O8
- IUPAC Name:
- 2-[({5-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-8-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid; 2-[({8-[(2-carboxycyclohexanecarbonyloxy)methyl]tricyclo[5.2.1.0²,⁶]decan-4-yl}methoxy)carbonyl]cyclohexane-1-carboxylic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): TCD-Emulgator
- Substance type: White crystals
- Physical state: Solid
- Lot/batch No.: 90003
- Sample no.: 498475/1990
- Expiration date of the lot/batch: 1992-01-08
- Storage condition of test material: At room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen/Kreis Paderborn
- Age at study initiation: 5-7 weeks
- Weight at study initiation: mean of 356 g (315-393 g)
- Housing: 5 animals per cage (Makrolon-cages type IV)
- Diet (e.g. ad libitum): Altromin 3020 pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): ca. 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (w/v)
Topical induction: 25 % (w/v)
Challenge: 25 % (w/v)
[25% is the maximum concentration that can be formulated]
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (w/v)
Topical induction: 25 % (w/v)
Challenge: 25 % (w/v)
[25% is the maximum concentration that can be formulated]
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
- Concentrations: 3, 6, 12 and 25 % (w/v)
- Test animals: 4
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: Intradermal -, topical induction 48 h
- Test groups: 1
- Control group: 1
- Site: dorso-cranial, -medial and -caudal
- Frequency of applications: Intradermal once initially, topical induction once after 7 d
- Duration: 7 d
- Concentrations: 5 % (w/v) for interdermal and 25 % (w/v) for topical
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 d after topical intradermal induction
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: Left flank for test substance application and right flank for negative control
- Concentrations: 25 % (w/v)
- Evaluation (hr after challenge): 48 and 72 h - Challenge controls:
- 10 negative control animals
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: test group. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
No symptoms and no mortalities occurred during the treatment. The gain in weight of the test group was equal to the control group. No skin reactions occurred during the experiment.
The clinical findings for the pilot study for the topical induction having applied test formulations of 3, 6, 12 to a maximum of 25 % are given below. The pilot studies of the same design for finding the application concentration for the challenge yielded exactly the same results for animals 41 to 45.
Erythema and edema:
Animal |
3 % |
6 % |
12 % |
25 % |
||||
48 h |
72 h |
48 h |
72 h |
48 h |
72 h |
48 h |
72 h |
|
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 |
The clinical findings for the challenge after 48 and 72 h having applied a 25 % (w/v) test formulation are given below.
Erythema and edema:
Animal |
Control group |
|||
Test substance patch |
Control patch |
|||
48 h |
72 h |
48 h |
72 h |
|
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Test substance group |
||||
21 |
0 |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
23 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
25 |
0 |
0 |
0 |
0 |
26 |
0 |
0 |
0 |
0 |
27 |
0 |
0 |
0 |
0 |
28 |
0 |
0 |
0 |
0 |
29 |
0 |
0 |
0 |
0 |
30 |
0 |
0 |
0 |
0 |
31 |
0 |
0 |
0 |
0 |
32 |
0 |
0 |
0 |
0 |
33 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
35 |
0 |
0 |
0 |
0 |
36 |
0 |
0 |
0 |
0 |
37 |
0 |
0 |
0 |
0 |
38 |
0 |
0 |
0 |
0 |
39 |
0 |
0 |
0 |
0 |
40 |
0 |
0 |
0 |
0 |
Bodyweights of animals of the control and test substance group on day 0 and 24 are given below.
Control group |
Test substance group |
||||
Animal |
bw [g] on day 0 |
bw [g] on Day 24 |
Animal |
bw [g] on day 0 |
bw [g] on Day 24 |
1 |
315 |
481 |
21 |
318 |
467 |
2 |
339 |
482 |
22 |
338 |
580 |
3 |
334 |
523 |
23 |
391 |
495 |
4 |
332 |
489 |
24 |
365 |
535 |
5 |
359 |
501 |
25 |
390 |
489 |
6 |
335 |
461 |
26 |
338 |
488 |
7 |
347 |
491 |
27 |
375 |
545 |
8 |
343 |
483 |
28 |
353 |
497 |
9 |
363 |
518 |
29 |
385 |
533 |
10 |
368 |
535 |
30 |
364 |
556 |
11 |
357 |
529 |
31 |
337 |
465 |
12 |
333 |
483 |
32 |
372 |
514 |
13 |
367 |
503 |
33 |
352 |
485 |
14 |
365 |
516 |
34 |
357 |
471 |
15 |
369 |
517 |
35 |
372 |
534 |
16 |
316 |
498 |
36 |
360 |
550 |
17 |
367 |
533 |
37 |
345 |
490 |
18 |
357 |
547 |
38 |
388 |
579 |
19 |
378 |
565 |
39 |
367 |
539 |
20 |
354 |
529 |
40 |
393 |
549 |
Mean |
350 |
509 |
Mean |
363 |
518 |
S |
18 |
26 |
S |
21 |
36 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After challenge with a 25 % formulation of the test item no skin reactions occurred, neither in the test nor in the control group. The test substance is considered not sensitising to the skin.
- Executive summary:
In a GLP-compliant dermal sensitisation study according to OECD guideline 406 with TCD-emulsifier (25 % w/v in polyethylene glycol E400), 20 male young adult guinea pigs (strain: Bor:DHPW) were tested using the method of Magnusson and Kligman (GPMT). No mortalities or clinical symptoms were observed. A 25 % solution of the test item (the maximum attainable concentration for formulations) did not cause primary irritation. Therefore, animals were treated with sodium lauryl sulfate (SLS) prior to topical application of the test item to induce skin irritation.
The animals of the test group were exposed intradermally (5 % w/v) to the test substance, followed by a single topical exposure (25 % w/v) after 7 days. The topical challenge (25 % w/v) was conducted 21 days after the initial intradermal induction for 24 h. Observations were made after 48 and 72 h. None of the exposed animals showed signs of an allergic reaction.
In this study, the test item is not a dermal sensitiser according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
