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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 July 1993 to 11 August 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
EC Number:
412-780-3
EC Name:
Reaction product of ammonium molybdate and C12-C24-diethoxylated alkylamine (1:5-1:3)
Cas Number:
1380226-46-9
Molecular formula:
A complex mixture of species so no unique molecular formula can be given
IUPAC Name:
dimolybdenum(6+) diammonium 2-{2-[(octadec-9-en-1-yl)amino]ethoxy}ethan-1-ol heptaoxidandiide
Test material form:
liquid: viscous
Details on test material:
- Name of test material: Additiv 104-Konzentrat
- Description: Dark red liquid
- Purity: Product by process; treated as 100% pure
- Lot/batch No.: DS 147
- Expiration date of the lot/batch: March 9, 1994
- Stability under storage conditions and up to 60 degrees C: Stable
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 8-10 weeks
- Weight at study initiation: Body weight at start of treatment within ± 20% of the sex mean
- Housing: Individually housed in labelled polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmuhle AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): relative humidity of 55%.
- Air changes (per hr): The room was air-conditioned with 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: 25cm2 for males and 18cm2 for females.
- Type of wrap if used: Flexible bandage (Coban, 3M, St. Paul, U.S.A.)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance were removed with tissue moistened with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Group 1: 2 ml/kg body weight. Group 2: 4 ml/kg body weight

Duration of exposure:
24 hours
Doses:
Group 1: 1000 mg/kg body weight.
Group 2: 2000 mg/kg body weight
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability recorded twice daily. Body weights recoded on Days 1 (pre—administration), 8 and 15.
- Necropsy of survivors performed: All animals surviving to the end of the observation period (day 15) were sacrificed by oxygen/carbon dioxide asphyxiation. All animals assigned to the study were subjected to necropsy and descriptions of all macroscopic abnormalities recorded.
- Other examinations performed: clinical signs recorded at periodic intervals on the day of treatment (day 1) and once daily thereafter. The time of
onset, degree and duration were recorded.
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: No clinical signs of ill health or behavioural changes were observed during the study period. Abnormalities on the treated skin area noted among theanimals included erythema (noted between days 2 and 15), scales (noted between days 4 and 15) and scabs (be
Gross pathology:
Macroscopic post mortem examination of the animals at termination revealed scab formation on the treated skin area in one male and one female exposed at 1000 mg/kg and reddish colouration and scab formation on the treated skin area of three females exposed at 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 values of the test substance in rats of either sex was established as exceeding 2000 mg/kg body weight
Executive summary:

In a GLP compliant, guideline acute dermal toxicity test the dermal LD50 values of the test substance in rats of either sex was established as exceeding 2000 mg/kg body weight. Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC), the test substance cannot be classified and has no obligatory labelling requirement.