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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Principles of method if other than guideline:
Method: other: OECD Guideline 429: Skin Sensitisation: Local Lymph Node Assay
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Details on test material:
Ethylenediamine, ethoxylated and propoxylated: Voranol RA 800; Average molecular mass: (average Mn = 240 g/mol)
; Units of Propylene oxide, approx: 70-90%, Units of ethylene oxide: approx 10-30%
Lot #: QD 09083024

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
- Strain: CBA/CA (BK1) mice
- Sex: female
- Source: B & K Universal Ltd, Hull, UK
- Age: 8-12 week
- Weight at study initiation: 15-23 g
- Number of animals: 20
- Individually housed. 
- Temperature 19-25°C
- relative humidity 30-70%

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
1st application: Induction 0.5 % open epicutaneous
2nd application: Induction 5 % open epicutaneous
3rd application: Induction 50 % open epicutaneous
No. of animals per dose:
5
Details on study design:
- Administration: The material was applied daily in 25 µl aliquots of the concentrations specified to the dorsal surface of each ear for three consecutive days. (day 0, 1, 2).
- Concentrations: 0, 0.5, 5, 50 % w/v. Determination of primary proliferation of lymphocytes:
- Cellular proliferation was determined by injection of 3H-methyl thymidine via the tail vein (20 µCi/mouse) Observations:
- All Animals were observed on a daily basis and the bodyweight of each mouse was recorded on day 0 (prior to dosing) and day 5 (prior to termination).
Statistics:
Linear regresssion followed by one way analysis of variance (ANOVA)

Results and discussion

Positive control results:
Report provides results of 6 positive controls that have been performed within 5 to 12 months before initiation of the study. All findings were positive.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Average Scores: Exposure onc.      Dpm        SI        Result control 1622        N/A          N/A 0.5% 1003        0.62      Negative 5% 1326        0.82      Negative 50% 8434        5.20      Positive

Any other information on results incl. tables

RESULTS OF TEST
- Sensitization reaction: 
_________________________________________
Conc.      Dpm        SI        Result
_________________________________________

control   1936
control   1844
control   1250
control   2042
control   1038
 average: 1622        N/A          N/A

  0.5%    2027
  0.5%     829
  0.5%     863
  0.5%     516
  0.5%     782
 average: 1003        0.62      Negative

   5%     1522
   5%      734
   5%     1382
   5%     1215
   5%     1775
 average: 1326        0.82      Negative

  50%     8882
  50%     8581
  50%    10728
  50%     5696
  50%     8282
 average: 8434        5.20      Positive
___________________________________________

- Clinical signs: No deaths nor signs of systemic toxicity
were noted in the test or control animals during the study.
Bodyweight changes in test group were comparable to those in
the control group.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information