Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
weight of evidence
Study period:
1990-09-10 to 1990-10-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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

Constituent 1
Reference substance name:
Witamol 118
IUPAC Name:
Witamol 118
Constituent 2
Reference substance name:
1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
EC Number:
275-809-7
EC Name:
1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
Cas Number:
71662-46-9
IUPAC Name:
71662-46-9
Details on test material:
- Name of test material (as cited in study report): WITAMOL 118
- Physical state: liquid
- Analytical purity: 99.5 %
- Lot/batch No.: 900706
- Expiration date of the lot/batch: 1991-07-06

- Molecular formula (if other than submission substance): C25 H40 O4
- Molecular weight (if other than submission substance): 404.60
- Smiles notation (if other than submission substance): CCCCCCCCCOC(=O)c1ccccc1C(=O)OCCCCCCCC

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 382-487 g
- Housing: 1 - 5 animals in Makrolon cages type IV
- Diet (e.g. ad libitum): G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days (main test)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 40 - 77
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
- Concentrations used for induction: intradermal treatment: approx. 5 % in corn oil; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): approx. 5 % test substance in a mixture of FCA and corn oil (1:1)
- Concentrations used for challenge: 100 %
No. of animals per dose:
test group: 20 animals
control group: 10 animals
Details on study design:
RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in corn oil (0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil) were applied intracutaneously into the left side of two animals. 24 hours after application the skin reactions were assessed. For dermal applications undiluted test substance and concentrations of 10, 20 and 50 g test substance/100 ml corn oil were applied on patches of 2x2 cm to the clipped skin of 4 animals. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle (5g/100 cm³) in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with sodium dodecyl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 100 %
- Evaluation: 24, 48 and 72 hours after application
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

RESULTS OF PILOT STUDY:

- intracutaneous application: well defined erythema and moderate edema at concentrations of 10 g test substance /100 ml corn oil. At concentrations of 0, 0.1, 0.5, 1, 2.5, 5 and 10 g test substance/100 ml corn oil very slight erythema and moderate edema were observed.

- dermal application: no skin reactions at any dose

RESULTS OF TEST

- Sensitization reaction: 0/20

- Clinical signs: no substance specific observations

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Witamol 118 did not induce delayed dermal sensitisation in the guinea pig.
Executive summary:

Delayed dermal sensitisation has been investigated using the maximisaton test according to OECD test guidelines. Witamol 118 did not induce delayed dermal sensitisation in the guinea pig.