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EC number: 500-007-3 | CAS number: 9003-50-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2016 to 03 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study was conducted in accordance with OECD, EU, EPA and Japanese test guidelines, in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Heptanal, oligomeric reaction products with aniline
- EC Number:
- 500-007-3
- EC Name:
- Heptanal, oligomeric reaction products with aniline
- Cas Number:
- 9003-50-3
- Molecular formula:
- (C7H14O)n.(C6H7N)n
- IUPAC Name:
- Heptanal, oligomeric reaction products with aniline
- Test material form:
- liquid
- Details on test material:
- Test item: 207368/A
Identification: Hepteen Base®
Appearance: Clear amber liquid (determined by Charles River Den Bosch)
Batch: LT5C30Y170
Purity/Composition: 99.7%
Test item storage: At room temperature
Stable under storage conditions until: 30 November 2016 (retest date)
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain, Crl:WI (Han) (outbred, SPF-Quality).
Recognized by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 5 males and 5 females (females were nulliparous and non-pregnant).
Age and body weight: Young adult animals (approx. 10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Tail mark with indelible ink.
Health inspection: At least prior to dosing. It was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality.
Animal Husbandry
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle: the photoperiod was between 07:00 and 19:00 hrs daily. The light/dark cycle may be interrupted for study related activities. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Single dosage, on Day 1.
- Duration of exposure:
- 24 hours, after which dressings were removed and the skin cleaned of residual test item using tap water.
- Doses:
- 2000 mg/kg (2.19 mL/kg) body weight.
- No. of animals per sex per dose:
- males and 5 females (females were nulliparous and non-pregnant).
- Control animals:
- no
- Details on study design:
- Test Item Preparation
The test item was dosed undiluted as delivered by the Sponsor.
No correction was made for the purity/composition of the test item.
Treatment
Method Dermal application. The test item was stirred on a magnetic stirrer during application.
Clipping One day before exposure (Day -1) an area of approximately 5x7 cm on the back of each animal was clipped.
Application: The test item was applied on an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).
Frequency: Single dosage, on Day 1.
Dose level (volume): 2000 mg/kg (2.19 mL/kg) body weight.
Application period: 24 hours, after which dressings were removed and the skin cleaned of residual test item using tap water.
Observations
Mortality/Viability Twice daily.
Body weights Days 1 (pre-administration), 8 and 15.
Clinical signs At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
Evaluation
A dermal LD50 value was derived.
The results were evaluated according to:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments);
- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of items and mixtures (including all amendments). - Statistics:
- Not specified.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Hunched posture, piloerection, quick breathing, shallow respiration, chromodacryorrhoea and/or ptosis were noted for the animals between Days 1 and 3
General erythema, erythema maculate, scales, scabs, wound and/or thickened areas were noted for the skin of the animals during the observation period. These local effects were considered not to have affected the conclusion of the study. - Body weight:
- Body weight loss or reduced body weight gain was noted for the male animals between Days 1 and 8.
The changes noted in body weight gain in females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity. - Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- None specified
Any other information on results incl. tables
Mortality Data
Test day |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Hours after treatment |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Males 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Females 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Clinical signs
Test day |
|
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Hours after treatment |
Max grade |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Males 2000 MG/KG |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANIMAL 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
2 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Scabs |
(3) |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Scabs (Flank left) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Snout) |
(3) |
- |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema |
(4) |
- |
- |
- |
3 |
3 |
2 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema maculate (treated skin) |
(4) |
- |
- |
- |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scabs (Left flank) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
Scabs (Treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Secrretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Ptosis |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shallow respiration |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General Erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
2 |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
Scabs (Flank left) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
Scabs (treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema maculate (treated skin) |
(4) |
- |
- |
- |
3 |
3 |
2 |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Scabs (Flank left) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Scabs (Treated skin) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (eye left) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Chromodacryorrhoea (eye right) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Chromodacryorrhoea (Snout) |
(3) |
- |
2 |
2 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Scabs (treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ptosis |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 2000 MG/KG |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANIMAL 6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
2 |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema maculate (Treated skin) |
(4) |
- |
- |
- |
1 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Scabs (Treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (snout) |
(3) |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
Scabs (Treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Thickened are (Treated area) |
(3) |
- |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ptosis |
(3) |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (treated skin) |
(4) |
- |
- |
- |
1 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema maculate (Treated skin) |
(4) |
- |
- |
- |
1 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Scabs(Treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema maculate (Treated skin |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
Scabs (Treated skin) |
(3) |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Thickened are (Treated skin) |
(3) |
- |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
(1) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Breathing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quick breathing |
(1) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General erythema (Treated skin) |
(4) |
- |
- |
- |
3 |
2 |
2 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Erythema Maculate (Treated skin) |
(4) |
- |
- |
- |
2 |
2 |
1 |
1 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
Piloerection |
(1) |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Scales (treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
Thickened area (Treated skin) |
(3) |
- |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = Sign not observed
Body weights
SEX/DOSE LEVEL |
Animal |
Day 1 |
Day 8 |
Day 15 |
Males 2000 MG/KG |
|
|
|
|
|
1 |
325 |
331 |
353 |
|
2 |
342 |
329 |
359 |
|
3 |
332 |
323 |
359 |
|
4 |
341 |
338 |
36 |
|
5 |
325 |
319 |
345 |
|
Mean |
333 |
328 |
356 |
|
ST.DEV. |
8 |
7 |
8 |
|
N |
5 |
5 |
5 |
Females 2000 MG/KG |
|
|
|
|
|
6 |
193 |
198 |
209 |
|
7 |
201 |
207 |
209 |
|
8 |
193 |
199 |
205 |
|
9 |
197 |
207 |
219 |
|
10 |
196 |
205 |
206 |
|
Mean |
196 |
203 |
210 |
|
ST.DEV. |
3 |
4 |
6 |
|
N |
5 |
5 |
5 |
Macroscopic findings
Animal |
Organ |
Finding |
Day of death |
Males 2000 MG/KG |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
1 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
2 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
3 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
4 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
5 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
Females 2000 MG/KG |
|
|
|
6 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
7 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
8 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
9 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
10 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Hepteen Base® in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, Hepteen Base® does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). - Executive summary:
Assessment of acute dermal toxicity with Hepteen Base® in the rat. The study was carried out based on the guidelines described in:
-OECD No.402 (1987) "Acute Dermal Toxicity"
-Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)"
-EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity"
-JMAFF Guidelines (2000), including the most recent revisions.
Hepteen Base® was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Hunched posture, piloerection, quick breathing, shallow respiration, chromodacryorrhoea and/or ptosis were noted for the animals between Days 1 and 3
Body weight loss or reduced body weight gain was noted for the male animals between Days 1 and 8.
The changes noted in body weight gain in females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of Hepteen Base® in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, Hepteen Base® does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.