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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:
28.01.2015 - 11.02.2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
On the basis of all evaluated data, the similarity of all category members of the ISOCARB is justified on basis of the physico-chemical properties, toxicological and ecotoxicological profiles. There is convincing evidence that these chemicals possess an overall common category profile.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid
EC Number:
941-570-9
Molecular formula:
C11H22O2
IUPAC Name:
Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2propyloctanoic acid
- Substance type: pure active substance, multi constituent
- Physical state: liquid
- Storage condition of test material: at room temperature / protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 09 -10 weeks old; females: 12 -13 weeks old
- Weight at study initiation: 239 - 248g (males); 200 - 225g (females)
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 1239)
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 02102140831)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ° C
- Humidity (%): 45 -65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2015-01-22 To: 2015-02-11

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: uniformly over an area
- % coverage: 10
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritation adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritation adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the exposure period the residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
To achieve a 100% of active component a correction factor of 1.0593x will be used.


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
To achieve a 100% of active component a correction factor of 1.0593x will be used.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 1; 8 and 15. Observations for evidence of dermal irritation were made all days.
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
no clinical signs of toxicity
Erythema grade 1 was observed in 1/5 female and 1/5 male animals. Crust was observed in 2/5 female animals. Desquamation was observed in all female and in 4/5 male animals. Scratches were observed in 3/5 animals of each gender.
All signs of irritation were not completely reversible within the observation period.
Body weight:
no significant effects
A slight weight loss was recorded for 2 out of 5 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation.
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was greater than 2000 mg/kg bodyweight in male and female rats.
Executive summary:

Under the conditions of the present study, single dermal application of the Category member 1 Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid to rats at a dose of 2000 mg/kg body weight was associated with no mortality and no signs of toxicity but slight signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid / kg body weight.