Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF test according to internal SOP
GLP compliance:
no
Remarks:
Conducted prior to GLP guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-iminodi(ethylamine)
EC Number:
203-865-4
EC Name:
2,2'-iminodi(ethylamine)
Cas Number:
111-40-0
Molecular formula:
C4H13N3
IUPAC Name:
N-(2-aminoethyl)ethane-1,2-diamine
Details on test material:
- Name of test material (as cited in study report): Diaethylentriamin (as named in study report); Substance ID: VI/236

Test animals

Species:
rabbit
Strain:
other: white rabbit
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
- Concentration (if solution): 40% and 100%
Duration of treatment / exposure:
1, 5, and 15 min
Observation period:
3 weeks
Number of animals:
2 animals used
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lutrol concentrated and 50% dilution in water used
- Time after start of exposure: 1, 5, 15 mins

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: 15 min
Remarks on result:
other: 100% Diethylenetriamine; upon substance removal very strong reddening with begining necrosis
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 15 min
Score:
0
Max. score:
0
Remarks on result:
other: 40% of diethylene triamine; No findings
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 15 min
Reversibility:
no data
Remarks on result:
other: 40% of diethylene triamine; visible erythema
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 5 min
Score:
0
Remarks on result:
other: 40% of diethylene triamine ; without findings
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: 15 min
Remarks on result:
other: 100% of diethylene triamine; upon substance removal very strong reddening with begining necrosis
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: Day 1
Remarks on result:
other: 100% of diethylene triamine; On day 1 greyish-brownish necrosis
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: Day 2
Remarks on result:
other: 100% diethylenetriamine; On day 2 leather-like blackish-brown crust-formation
Irritation parameter:
other: necrosis
Basis:
animal #1
Time point:
other: 3 weeks
Reversibility:
not reversible
Remarks on result:
other: 100% Diethylenetriamine; deep scar 3 weeks later
Irritation parameter:
other: necrosis
Basis:
animal #2
Time point:
other: 15 min
Remarks on result:
other: 100% Diethylenetriamine; blackish-brown necrosis, bleeding, marginal red swelling
Irritation parameter:
other: necrosis
Basis:
animal #2
Time point:
other: 15 min
Reversibility:
no data
Remarks on result:
other: 100% of diethylene triamine; blackish-brown necrosis, bleeding, marginal red swelling
Irritant / corrosive response data:
Refer to remarks below
Other effects:
Refer to remarks below

Any other information on results incl. tables

40% of diethylene triamine

15 min exposure:

1 animal without findings, one animal visible erythema

5 min exposure: without findings

1 min exposure: without findings

100% of diethylene triamine:

15 minutes exposure:

1st animal: upon substance removal very strong reddening with begining necrosis. On day 1 greyish-brownish necrosis; on day 2 leather-like blackish-brown crust-formation with remaining deep scar 3 weeks later

2nd animal: blackish-brown necrosis, bleeding, marginal red swelling

5 min of exposure:

1st animal: upon substance removal: reddening, spotted necrosis; on day 1 grey-brownish necrosis; on day 2 leather-like blackish-brown crust formation with remaining deep deep scar 3 weeks latter.

2nd animal ; upon substance removal; Tan necrosis, bleeding, marginal red swellling; on day 1 anaemic necrosis with marginal reddening; 8 day hard crust formation with remainning scar after 3 weeks

1 min of exposure: upon substance removal slight reddening, partly necrotic wtih marginal reddening; on day 1 slight reddening and pea sized necrosis; On day 2 spotted reddening with pea-sized necrosis; on day 8 spotted crusts with remaining scars.

Applicant's summary and conclusion

Conclusions:
A 15 minute exposure to DETA resulted in necrosis in two of two rabbits.
Executive summary:

The skin irritation potential of DETA was examined. A 15 minute exposure to DETA resulted in necrosis in two of two rabbits.