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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3'-oxybis(ethyleneoxy)bis(propylamine)
EC Number:
224-207-2
EC Name:
3,3'-oxybis(ethyleneoxy)bis(propylamine)
Cas Number:
4246-51-9
Molecular formula:
C10H24N2O3
IUPAC Name:
3,3'-[oxybis(ethane-2,1-diyloxy)]dipropan-1-amine
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Impurities: 4,7-Dioxanonan-9-ol-1-amin
- Expiration date of the lot/batch: July 1985

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 259 g; mean females: 218 g
- Housing: single housing (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- 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: ca. 50 cm² of shaved dorsal/dorsolateral skin
- Type of wrap if used: semiocclusive

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

TEST MATERIAL
- Amount applied: 2.15 mL/kg
- Concentration: undiluted
Duration of exposure:
24 hours
Doses:
2150 mg/kg
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: check for mortality/moribund animals twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: assessment of local effects (30 - 60 min after removal of semiocclusive coverage and afterwards at least once per week)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 150 mg/kg bw
Based on:
test mat.
Mortality:
One male animal died 2 days after application of the test substance.
Clinical signs:
Clinical signs included dyspnoea, apathy, aggressiveness, staggering, poor general state.
Body weight:
See table below.
Gross pathology:
Animal that died: lungs: severe edema
Sacrificed animals: no abnormalities in organs observed
Other findings:
Local skin effects: 1 male animal moderate, 1 male animal superficial erosions with crust formation; other animals: profound necrosis.

Any other information on results incl. tables

Mortality:

Dose (mg/kg)

2150

Males

Dead animals/total animals after

1 h

0/5

1 d

0/5

2 d

1/5

7 d

1/5

14 d

1/5

Females

Dead animals/total animals after

1 h

0/5

1 d

0/5

2 d

0/5

7 d

0/5

14 d

0/5

 

Mean body weights (g):

 

Dose

(mg/kg)

Weight day

0

2

6

13

Males

2150

259

241

263

292

Females

2150

218

241

211

231

 

Symptoms (cageside observations):

Dose (mg/kg)

2150

Males

Dyspnoea

2D-5D

Apathy

2D-5D

Agressiveness

8D-9D

Staggering

2D-5D

Poor general state

2D-5D

Females

Dyspnoea

2D-6D

Apathy

2D-5D

Agressiveness

6D-9D

Staggering

2D-6D

Poor general state

2D-6D

D: Day

 

Local effects

Dose (mg/kg)

2150

Males

Profound necrosis

1D-14D

Edema

1D-14D

Females

Profound necrosis

1D-14D

Edema

1D-14D

D: Day

Applicant's summary and conclusion

Interpretation of results:
other: slightly toxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.
Executive summary:

Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.