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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-02-29 to 1988-03-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
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:
Magnusson & Kligman maximisation test (J. Invest. Dermatol. 52, 268-276, 1969)
GLP compliance:
no
Type of study:
Freund's complete adjuvant test

Test material

Constituent 1
Reference substance name:
Octylphenol PT
IUPAC Name:
Octylphenol PT
Constituent 2
Chemical structure
Reference substance name:
4-(1,1,3,3-tetramethylbutyl)phenol
EC Number:
205-426-2
EC Name:
4-(1,1,3,3-tetramethylbutyl)phenol
Cas Number:
140-66-9
Molecular formula:
C14H22O
IUPAC Name:
4-(1,1,3,3-tetramethylbutyl)phenol
Details on test material:
- Name of test material (as cited in study report): 1,1,3,3-Tetramethylbutylphenol (Octylphenol PT)
- Physical state: solid
- Analytical purity: 96%
- Impurities (identity and concentrations): ca. 1 % 1,1,3,4-Tetramethylbutylphenol; ca. 2% 1,1,2-Tetramethylpentylphenol; < 1% 0-1,1,3,3-Tetramethylbutylphenol

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: average 335.5 g (control group) and 341.2 g (test group)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 17 days

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Induction (intradermal):
A: 0.1 ml Freunds Complete Adjuvants (FCA): H2O (1:1)
B: 0.1 ml 1% OP in corn oil;
C: 0.1 ml 1% OP in FCA:corn oil (1:1)
control group received the same type of injections but without substance

Challenge (patch test):
one week after injection: 50% OP on 2 x 4 cm filter paper for 48 h
two weeks after injection: 20% OP on 2 x 2 cm filter paper for 24 h
control group was challenged only once (14 days after injection)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction (intradermal):
A: 0.1 ml Freunds Complete Adjuvants (FCA): H2O (1:1)
B: 0.1 ml 1% OP in corn oil;
C: 0.1 ml 1% OP in FCA:corn oil (1:1)
control group received the same type of injections but without substance

Challenge (patch test):
one week after injection: 50% OP on 2 x 4 cm filter paper for 48 h
two weeks after injection: 20% OP on 2 x 2 cm filter paper for 24 h
control group was challenged only once (14 days after injection)
No. of animals per dose:
test animals: 20
control animals: 10
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 1 (in duplicates)
- Exposure period: intracutaneous injections (0.1 cm³)
- Concentration in Freunds Complete Adjuvants (FCA):50% in H2O
- Test group: FCA w/o test substance; test substance in corn oil; test substance in FCA:corn oil (1:1)
- Control group: FRCA in water; corn oil; FCA:corn oil (1:1)
- Frequency of applications: day 0: intradermal treatment, days 7 and 14 : patch test
- Duration: 3 weeks
- Concentrations: 1% v/v, test substance was melt

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 7 & 14
- Exposure period: 48 & 24 h
- Test groups: 50% & 20 % test substance in corn oil
- Control group: day 7: corn oil; day 14: 20 % test substance in corn oil
- Site: left flanks
- Evaluation (hr after challenge): 48 and 72 hours after application
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
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: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
20 %
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: 20 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
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: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
20 %
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: 20 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

RESULTS OF TEST

- Sensitization reaction: All animals of the control group and of the test group showed no specific findings after 48 an 72 h after the second challenge (Score = 0).

- Clinical signs:

1. The test and control animals showed a normal body weight gain throughout the investigation.

2. After intradermal induction: All induction sites of test and control animals treated with FCA showed intense erythema, swelling and necrosis. Treatment with 1% test substance in corn oil induced distinct erythema and swelling. Corn oil showed slight erythema and swelling.

3. After patch test: All induction sites with FCA showed bloody inflammations. 24 hours after patch removal distinct erythema and swelling on the application sites and at the shoulder area (test animals). All injection sites showed incrustations (test and control animals).

Due to local effects only results of tests without FCA were considered in the evaluation of the sensitizing potential.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
1,1,3,3-Tetramethylbutylphenol has no sensitizing potential in a guinea pig maximization test (OECD 406) after intradermal induction with 1% and challenge with 50% and 20% after 7 and 14 days.
Executive summary:

In a dermal sensitization study with 1,1,3,3-Tetramethylbutylphenol (96%) in corn oil or FCA/corn oil, 20, female albino guinea pigs (Bor:DHPW) were tested using the method of Magnussen-Kligman. 

All induction sites of test and control animals treated with FCA showed intense erythema, swelling and necrosis. Treatment with 1% test substance in corn oil induced distinct erythema and swelling. Corn oil showed slight erythema and swelling. After patch test all induction sites with FCA showed bloody inflammations. 24 hours after patch removal distinct erythema and swelling occurred on the application sites and at the shoulder area (test animals). All injection sites showed incrustations (test and control animals).

Distinct local effects are caused by the irritating properties of the substance. (1,1,3,3 -Tetramethylbutyl)phenol is not considered a dermal sensitizer based on an OECD 406 guideline study.

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