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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:
23.07.1985 - 12.08.1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4
- Name of test material (as cited in study report): N,N-dimethyl-N-butylamine
- Substance type: aliphatic amine
- Physical state: liquid
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Tuck & Sons Ltd, Battlesbridge, Essex, UK
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: males 223-258 g; females 190- 207 g
- Housing: individually during the 24 h exposure period and then in groups of 5 by sex for the remainder of of the study
- Diet: standard laboratory rodent diet ad libitum
- Water: ad libitum
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/-2°C
- Humidity: 60-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6x12 cm
- % coverage: 10%
- Type of wrap if used: a patch of surgical gauze was held in palce with a strip of elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes; with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw; dose volume 2.78 mL/kg bw
- Constant volume or concentration used: na.a.; one dose only
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- observations: 0.5, 1, 2, 3, 4, and 5 hours following dosing, and then at least one per day
--weighing: on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
not needed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mL/kg bw
Based on:
test mat.
Remarks on result:
other: free base
Mortality:
No deaths occurred in the rangefinding or in the main study (i.e. 0 deaths in 14 exposed animals)
Clinical signs:
None of the rats showed clinical signs as repsonse to treatment.
Body weight:
Ther was no toxicologically significant effect on body weight in any rat.
Gross pathology:
No findings in final necropsies in any rat.
Other findings:
No local effects were reported.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: other: lack of acute (systemic) toxicity; local skin effects (corrosion) was not reported but must be taken into consideration
Conclusions:
The dermal LD50 was >2000 mg/kg bw in the rat.
Executive summary:

The acute dermal toxicity of N,N-dimethylbutylamine (2000 mg/kg bw; free base) was examined in a rat study (5 male and female Sprague Dawley rats) that was conducted according to OECD 402 and under GLP conditions. There were no deaths or clinical signs of toxicity including body weight in any of the rats within the 14-day observation period. Local skin effects were not reported but must be assumed because of the corrosivity of the free base. Thus the dermal LD50 in the rat was >2000 mg/kg bw in this study (Hewitt and Collier,1985).

 

This study is considered to be valid and suitable for assessment.