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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read-across, GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The Guideline 429 was 1998 not yet available/adopted.
Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH Laboratory Animal Breeders, 33176 Borchen, Germany
- Age at study initiation: 3 - 5 weeks
- Diet: ad libitum
- Water: ad libitum
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Remarks:
400
Concentration / amount:
Dose-finding study:
- intradermal injection with 0, 1, 2.5, and 5% (at 1% grey injection site after 24 hours and red wheal after 48 hours)
- topical application with 0, 6, 12, and 25%
- challenge with 0, 6, 12, 25%
Based on the results the following concentrations for the main study were selected:
- intradermal injection for induction: 1% (= 4 mg test item/animal)
- topical application for induction and challenge: 25% (= 125 mg test item/animal)
From preliminary investigations 25% in PEG 400 were visually described as suspension.
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
400
Concentration / amount:
Dose-finding study:
- intradermal injection with 0, 1, 2.5, and 5% (at 1% grey injection site after 24 hours and red wheal after 48 hours)
- topical application with 0, 6, 12, and 25%
- challenge with 0, 6, 12, 25%
Based on the results the following concentrations for the main study were selected:
- intradermal injection for induction: 1% (= 4 mg test item/animal)
- topical application for induction and challenge: 25% (= 125 mg test item/animal)
From preliminary investigations 25% in PEG 400 were visually described as suspension.
No. of animals per dose:
10 animals in test group, 5 animals in control group
Positive control substance(s):
yes
Remarks:
the sensitivity of the test is checked periodically with 2-mercaptobenzothiazole
Vehicle:
other: PBS buffer
Concentration:
0, 1, 10, 50 %
No. of animals per dose:
6
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION:
The test item in the formulation or the vehicle were applied epicutaneously onto the dorsal part of both ears of the animals. This  treatment was repeated on three consecutive days (d0, d1 and d2). The volume administered was 25µl/ear. The used concentrations were based on the experiences with the test system and the toxic properties of the test substance.
The animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after the last application (d3). The appropriate organs were then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiological saline (PBS).
Investigations:
- weight of draining lymph nodes (given as weight index compared to vehicle controls)
- cell counts in draining lymph nodes (given as cell count index compared to vehicle controls)
Stimulation indices were calculated by dividing the absolute weight or number of cell counts of the substance treated lymph nodes by the vehicle treated ones.
- ear swelling (given in 0.01 mm and as index)
- ear weight (given in mg/8 mm diameter punch and as index)
Positive control substance(s):
not specified
Statistics:
When it was statistically reasonable, the values from treated groups were compared with those from the control group by the Mann-Whitney or the Wilcoxon signigicance test (U-test) at significance levels of 5 and 1% (one-tailed for LLNA/IMDS or PNLA (larger)). Outlying values in the LN/ear weights or LN cell counts were eliminated at a probability level of 99% by Nalimov's method. In addition, for the LLNA/IMDS the smallest significant differentes in the means were calculated by Scheffels method, which according to Sachs can be used for both equal and unequal sample sizes.
Reading:
other: 1st and 2nd reading
Group:
test chemical
Dose level:
1% for intradermal induction, 25% for topical induction, 25% for challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: other: 1st and 2nd reading. Group: test group. Dose level: 1% for intradermal induction, 25% for topical induction, 25% for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
other: 1st and 2nd reading
Group:
negative control
Dose level:
25% for challenge
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: other: 1st and 2nd reading. Group: negative control. Dose level: 25% for challenge. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
No significant dose-dependent increase in the stimulation indices for the weight or cell counts in the lymph nodes as well as for ear swelling or ear weights was seen and statistical analysis revealed no significant effect for the test item ethoxyamidin. However, the cell count index of the mid dose group exceeded the 'positive level' which is 1.25.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:
Bay u 3405 HS was investigated for skin sensitization in the Guinea Pig Maximization Test according to OECD TG 406. Ten Guinea pigs were dosed for intradermal induction (1%), topical induction (25%) and for topical challenge (25%) in PEG 400. The results show that the test item has no skin sensitizing potential in Guinea pigs under the conditions of this test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Bay u 3405 HS was investigated for skin sensitization in the Guinea Pig Maximization Test according to OECD TG 406. Ten Guinea pigs were dosed for intradermal induction (1%), topical induction (25%) and for topical challenge (25%) in PEG 400. The results show that the test item has no skin sensitizing potential in Guinea pigs under the conditions of this test.


Migrated from Short description of key information:
BA-Salz should be regarded as no skin sensitizer, based on data for Bay u 3405.

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) for skin sensitization is not warranted.