Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.09-21.10.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethanolamine
- Physical state: clear, colourless liquid
- Analytical purity: 98.9 %
- Impurities (identity and concentrations): 0.4 % DEA, 0,6 % Triethanolamineglycolether
- Purity test date: 14.07.1988
- Lot/batch No.: sample 838, B 255 A (03.06.1988)
- Stability under test conditions: in the dark
- Storage condition of test material: 20°C

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Strain: Hoe: DHPK(SPFLac)
- Weight at study initiation: x = 313g (=100 %); xmin= 286g (- 8,6%); * xmax= 337g (+ 7,7%); n = 15
- Housing: 5/ cage
- Diet: ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 2 %
dermal induction: unchanged
dermal challenge: 10 %
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 2 %
dermal induction: unchanged
dermal challenge: 10 %
No. of animals per dose:
pretest: 6 (determination of the non-irritating concentration
determination of the intradermal tolerance: 3
control group 1: 5
control group 2: 5
treatment group: 10
Details on study design:
RANGE FINDING TESTS: (dermal occlusive on the flank skin): 100%, 10% and 1% in saline
The animal's fur was clipped and 0.5 ml of the test substance was applied on a patch that was fixed on the skin under occlusive condition for 24 hours. After 24 hours the patch was removed and the skin was assessed another 24 hiurs later for erythema and oedema reactions.

To study the intradermal tolerance of the test substance, the substance was injected in concentrations of 0.2 %, 1 % and 5 % intradermally in the skin of the back, each concentration at two seperate areas.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal) and 1 epicutaneous
- Exposure period: 48 hours (epicutaneous)
- Test groups: 2x 0.1 ml at a concentration of 2 % in 50% Freunds adjuvans; 2x 0.1 ml at a concentration of 2 % in NaCl 0.9 %; 2x 0.1 ml of 50% Freunds adjuvans (intradermal)
0.5 ml of the test substance or vehicle was applied on a 2 x 4 cm patch which was applied for 48 hours to the animal's skin under occlusive conditions
- Control group: 2x 0.1 ml of 50% Freunds adjuvans; 2x 0.1 ml NaCl 0.9 %; 2x 0.1 ml of 50% Freunds adjuvans (intradermal
- Site: skin of the back


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 0.5 ml of the 10 % test substance or vehicle was applied on a 2 x 2 cm patch which was applied for 24 hours to the animal's skin under occlusive conditions
- Control group: 0.5 ml of the 10 % test substance in saline
- Site: flank skin
- Evaluation (hr after challenge): 48 hours, 72 hours


OTHER: Time scale:
day 0: determination of body weight
day 1: intradermal induction
day 9: dermal induction
day 11: evaluation of skin irritation
day 22: dermal challenge
day 23: removal of occlusive dressing
day 24: 1st evaluation
day 25: 2nd evaluation

Scoring:
equivalent to Draize scores
Challenge controls:
yes
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none .
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Body weight development:

mean body weight gain:

control group: 30.8 %

Treatment group: 35.7 %

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing