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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-02-27 to 1991-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
EC Number:
247-063-2
EC Name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
Cas Number:
25513-64-8
Molecular formula:
C9H22N2
IUPAC Name:
2,2,4-trimethylhexane-1,6-diamine; 2,4,4-trimethylhexane-1,6-diamine
Test material form:
other: colourless liqiud
Details on test material:
no data, test material was used as supplied

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white
- Sex: male/female
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Weight at study initiation: 2.14 - 2.77 kg
- Age: approx. 12 - 16 weeks
- Acclimatisation: five days
HOUSING CONDITIONS:
- Room temperature: 18 - 22°C
- Humidity: 50 - 59%
- Light: 12 hours/day
- Air exchange: 15-fold/h
- Access to drinking water: ad libitum
- Diet: diet for rabbits (Spillers Rabbit Diet)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
1.5 hours and 3 minutes
Observation period:
1.5 hours treatment: after 1 hour; following the 1-hour observation all animals were killed for humane reasons
3 minutes treatment: after 1 hour, 24 and 48 hours; following the 48-hour observation all animals were killed for humane reasons
Number of animals:
6 (3 per sex)
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: ca. 6 cm2
- Total volume applied: 0.5 ml
- Postexposure period: 
1.25 hours treatment: after 1 hour
3 minutes treatment: after 1 hour, 24 and 48 hours
- Removal of test substance: with gentle swabbing with cotton wool soaked in diethyl ether
EXAMINATIONS
- Scoring system: Draize scale
- Examination time points: 
1.5 hours treatment: after 1 hour
3 minutes treatment: after 1 hour, 24 and 48 hours

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
modified, 3 minutes exposure
Basis:
mean
Time point:
other: 24 hours observation
Score:
8
Max. score:
8
Reversibility:
not reversible
Irritant / corrosive response data:
Modified primary irritation index: 8.0 based on erythema values at 24 hour observation only, 3 minutes exposure
Classification: corrosive
Other effects:
no

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
A study was performed to examine skin irritating effects of the test item ccording to OECD TG 404 in rabbits. In the study three rabbits per sex were
exposed occlusively for 3 minutes and 1.5 hours. The reactions were considered to be indicative of corrosion. The test material also produced a
modified primary irritation index of 8.0 (based on erythema values at the 24-hour observation only).
Air Products
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the DECO Guidelines for Testing of Chemicals ( 1981) No. 404 "Acute Derma 1 Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC {which constitutes Annex V of


Council Directive 67/548/EEC).


A single 1.5 hour, semi-occluded application of the test material to the intact skin of three rabbits produced severe dermal necrosis,


haemorrhage of the dermal capillaries and loss of skin elasticity and flexibility. These reactions also extended beyond the treatment site.


A single 3-minute, semi-occluded application of the test material to an additional group of three rabbits produced dermal necrosis, severe haemorrhage of the dermal capillaries and the formation of an undulating, hardened dark brown/black coloured scab. Other adverse dermal reactions noted were moderate to well-defined erythema surrounding the treatment site, slight to serve oedema and oedema dropping ventrally below the treatment site. The reactions also extended beyond the treatment site.


These reactions were considered to be indicative of corrosion.