Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets generally accepted scientific principles. Study is well documented, before OECD TG and GLP existed. The study is fully sufficient for endpoint evaluation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Some details were not reported including the age of animals as well as further details on test animals and environmental conditions. No information was avaliable in terms of the type of coverage used.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisopropylamin
- Physical state: liquid
- Analytical purity: >= 99.0 %
- Impurities (identity and concentrations): no data given

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Average weight at study initiation: males ca. 150 g; females ca. 130 g
- Diet: Ssniff - Herilan MRH

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: no vehicle was used, except for 400 mg/kg bw dose (50 % olive oil)
Details on dermal exposure:
TEST MATERIAL
- Concentration (if solution): 100 % of the test material was applied, except for the 400 mg/kg bw dose: here the test material was diluted in 50 % olive oil
- Constant volume or concentration used: no
Duration of exposure:
14 days
Doses:
5000, 2000, 1000 and 400 mg/kg bw.
No. of animals per sex per dose:
2000, 1000 and 400 mg/kg bw: 5 animals per sex per dose
5000 mg/kg bw: 3 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1h, day 1, then daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Mortality:
5000 mg/kg bw: 3/3 males and 3/3 females died after 24 hours.
2000 mg/kg bw: 0/5 males and 0/5 females died within 14 days.
1000 mg/kg bw: 0/5 males and 0/5 females died within 14 days.
400 mg/kg bw: 0/5 males and 0/5 females died within 14 days.
Clinical signs:
5000 mg/kg bw: grey to green soft necroses were seen in all animals after 24 hours.
2000 mg/kg bw: After application of the test material, all animals screamed and slight apathy was observed during 12 further days. After 24 hours, red discharge in the eyes of the animals was observed.
1000 mg/kg bw: from 24 hours after application of the test material until day 14, the animals appeared lively.
400 mg/kg bw: from 24 hours after application of the test material until day 14, the animals appeared lively.
Body weight:
The individual body weight of the animals was only determined at the day of application of the test material. No further data was available.
Gross pathology:
5000 mg/kg bw: cadaverous
2000 mg/kg bw: the organs were without any findings.
1000 mg/kg bw: the organs were without any findings.
400 mg/kg bw: the organs were without any findings.
Other findings:
Necroses were seen in all animals on the application sites from 24 h after application of the test material until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Executive summary:

The acute dermal toxicity of Diisopropylamine (DIPA) was evaluated in rats according to a protocol similar to the OECD N° 402 guideline. DIPA was applied to the skin of groups of 5 male and 5 female Sprague Dawley rats at doses of 2000, 1000 and 400 mg/kg and 3 male and 3 female Sprague Dawley rats at 5000 mg/kg. Animals were observed 1 hour after application and then daily for 14 days.

Necroses were seen in all animals on the application sites from 24 h after application of the test material until the end of the observation period.

At 5000 mg/kg, 3/3 males and 3/3 females died after 24 hours.

At 2000 mg/kg, 0/5 males and 0/5 females died within 14 days.

At 1000 mg/kg, 0/5 males and 0/5 females died within 14 days.

At 400 mg/kg, 0/5 males and 0/5 females died within 14 days.

At 5000 mg/kg, grey to green soft necroses were seen in all animals after 24 hours.

After application of 2000 mg/kg, all animals screamed and slight apathy was observed during 12 further days. After 24 hours, red discharge in the eyes of the animals was observed.

From 24 hours after application of 1000 mg/kg of DIPA until day 14, the animals appeared lively.

From 24 hours after application of 400 mg/kg of DIPA until day 14, the animals appeared lively.

At 5000 mg/kg, organs looked cadaverous. At 2000 mg/kg and below, the organs were without any findings.

Under these experimental conditions, the dermal LD50 of DIPA is higher than 2000 mg/kg and lower than 5000 mg/kg in Sprague Dawley rats.