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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:
1984-09-25 to 1984-10-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of 2,2,4-trimethylhexa-1,6-diyl diisocyanate and 2,4,4-trimethylhexa-1,6-diyl diisocyanate
EC Number:
915-277-1
Cas Number:
32052-51-0
Molecular formula:
C11H18N2O2
IUPAC Name:
Reaction mass of 2,2,4-trimethylhexa-1,6-diyl diisocyanate and 2,4,4-trimethylhexa-1,6-diyl diisocyanate
Test material form:
other: liquid
Details on test material:
2,2,4-/2,4,4-trimethylhexane-1,6-diisocyanate of Hüls AG, purity > 99.0 %

Test animals

Species:
rabbit
Strain:
other: Small white Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.2 - 2.6 kg
- Number of animals: 3 males, 3 females
Housing conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%); light: 12 hours/day
- Air exchange: 15-fold/h
- Access to drinking water: ad libitum
- Diet: K4 diet for rabbits (Ssniff; Soest)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: no vehicle
Amount / concentration applied:
0.5 ml, undiluted
Duration of treatment / exposure:
4 hour(s)
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm2
- Total volume applied: 0.5 ml
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with deionized water
- Post exposure period: 3 weeks
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and  Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10, 14, and 21 days  after patch removal; evaluation based on readings 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
5.13
Max. score:
8
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.44
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 2.67
- Edema: 2.44
- irritation index: 5.13/8
REVERSIBILITY: Not reversible. Necrosis within 4 hours, not within 3  minutes. Eschars, incrustation, or scars by end of study in all animals.
Other effects:
no other effects

Any other information on results incl. tables

no further results

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test item 2,2,4 -/2,4,4 -trimethylhexane-1,6 -diisocyanate showed severe damage on the skin
of male and female rabbits.y. All rabbits showed eschars, incrustation, or scars by end of  study.
Executive summary:

A study was performed to examine skin irritating effects of 2,2,4-/2,4,4-trimethylhexane-1,6-diisocyanate according to OECD TG 404 in rabbits. Undiluted test substance was applied in the study. In the study three rabbits per sex were exposed occlusively for four hours. Necrosis within 4 hours, not within 3  minutes was observed .  All rabbits showed eschars, incrustation, or scars by end of  study. The result was, with regard to the irritation index (5.13 of max. 8.0), described as “highly irritating”.