Pentamethylenediamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Read-across

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Hexamethylenediamine

EC Number:

204-679-6

EC Name:

Hexamethylenediamine

Cas Number:

124-09-4

Molecular formula:

C6H16N2

IUPAC Name:

hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): hexamethylenediamine
- Molecular formula (if other than submission substance): C6H16N2
- Molecular weight (if other than submission substance): 116.2046
- Smiles notation (if other than submission substance): NCCCCCCN
- InChl (if other than submission substance): InChI=1/C6H16N2/c7-5-3-1-2-4-6-8/h1-8H2
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: organic
- Physical state: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ONCINS, IFFA CREDO
- Age at study initiation: No data
- Weight at study initiation: 120 to 150g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 X 6 cm2
- % coverage: No data
- Type of wrap if used: aluminium + adhesive plaster


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soapy water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): volume of the substance itself
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

950, 1400, 2000, 3000 or 4800 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals in the higher non-lethal dose group were weighed once every 5 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

LD 50 was calculated according to Dragstedt & Lang

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 900 mg/kg bw

Mortality:

See table 7.2.3/1

Clinical signs:

other: Lower motricity in the three higher dose groups, closed eyes and low body temperature in some animals of the three higher dose groups.

Gross pathology:

At dose levels of 4300, 3000 and 2000 mg/kg bw, 24 hours after treatment, necrosis appeared on all the treated surface, without cicatrisation at death time.
At dose levels of 1400 and 950 mg/kg bw, necrosis formation was observed in day 1 after exposure. Necrosis was recovered every day by a scab, up to the end of the observation period.

Other findings:

No data

Any other information on results incl. tables

Table 7.2.3/1: Number of animals dead

Dose (mg/kg bw)	Mortality (x/number of rats)	DL50 after 15 observation days (mg/kg bw)
4800	10/10	Approximately 1900
3000	10/10
2000	6/10
1400	0/10
950	0/10

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU