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Diss Factsheets

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:
09 - 23 Apr 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The studies were conducted within the scope of global registration outside the European Union and outside REACH.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 24 Apr 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis[2-[(2-aminoethyl)amino]ethanolato][2-[(2-aminoethyl)amino]ethanolato-O](propan-2-olato)titanate
EC Number:
265-723-8
EC Name:
Bis[2-[(2-aminoethyl)amino]ethanolato][2-[(2-aminoethyl)amino]ethanolato-O](propan-2-olato)titanate
Cas Number:
65380-84-9
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
2-methyl-4,4-bis(propan-2-yloxy)-3,5-dioxa-8-aza-4-titanadecan-10-amine; 7,7-bis(propan-2-yloxy)-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; 7,7-bis({2-[(2-aminoethyl)amino]ethoxy})-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; 7-{2-[(2-aminoethyl)amino]ethoxy}-7-(propan-2-yloxy)-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; tetrakis(propan-2-yloxy)titanium

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., Denver, Pennsylvania, USA
- Weight at study initiation: 2.9 kg
- Housing: individually in suspended wire bottom cages with paper bedding
- Diet: PMI Rabbit Chow, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
Initial test (animal #1): 3 min, 1 and 4 h
Confirmatory test (animals #2 and #3): 1 and 4 h
Observation period:
14 days
Reading time points: 1 h (3 min exposure period) and 1, 24, 48 and 72 h and 7 and 14 days (1 and 4 h exposure period)
Number of animals:
1 male, 2 female
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 on the dorsal area of the trunk
- Type of wrap if used: A piece of porous dressing was secured with non-irriraring tape over dose sites.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed from the test site by gently washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions.
- Time after start of exposure: 3 min, 1 or 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 7 and 14 days

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days of observation
Remarks on result:
other: 4 h exposure period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days of observation
Remarks on result:
other: 4 h exposure period
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days of observation
Remarks on result:
other: 4 h exposure period
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days of observation
Remarks on result:
other: 4 h exposure period
Irritant / corrosive response data:
3 min exposure period: Immediately following the exposure, and at 60 min, erythema and edema were absent.

4 h exposure period: At the 1 h reading time point, very slight erythema (score 1) was observed in 3/3 animals, very slight edema (score 1) in 2/3 and slight edema (score 2) in 1/3 animals. At 24 h post exposure, erythema was well defined (score 2) in all animals and residual test article was observed. Edema was very slight (score 1) in all animals. At 48 h post exposure, erythema was well defined (score 2, 1/3 animals) to severe (score 3, 2/3 animals). Residual test material was noted on the test site of 2/3 animals and dark areas were observed in 1/3 animals. Slight edema (score 1) was observed in all animals. At 72 h post exposure, 2/3 animals still showed severe erythema (score 3) and 1/3 animals (no. 2) showed slight edema. One animal (no. 2) still exhibited test material on the skin and had dark areas. Very slight edema (score 1) was observed in 2/3 animals and slight edema in 1/3 animals. After 7 days of observations, 1/3 rabbits showed slight erythema (score 1) but cracking skin and shiny areas, 1/3 rabbits showed well defined erythema (score 2) and shiny areas and 1/3 rabbits (no. 2) showed severe eschar formation (score 4) with shiny areas. Very slight edema formation (score 1) was observed in 1/3 animals, the other two animals showed no edema formation. After 14 days of observation, slight erythema was still present in 1/3 animals (no. 2), while the other animals fully recovered. Edema formation was no longer observed.

1h exposure period: At the 1 h reading time point, erythema was absent and very slight edema was observed in 2/3 animals. At 24 h post exposure, slight erythema was present in 2/3 rabbits and remaining test material was observed in all animals. Edema formation was no longer observed. At 48 h post exposure, slight erythema was observed in 1/3 animals (score 1) and 2/3 animals still exhibited test material on the test site. At 72 h post exposure, slight erythema (score 1) was observed in 1/3 rabbits and well defined erythema (score 2) in 1/3 rabbits. The well defined erythema in animal no. 3 was still present after 7 days of observation, but reversible until the end of the 14 day observation period. Edema formation was observed in 1/3 animals 7 days after administration, but fully reversible in all animals until the end of the 14 day observation period.

Any other information on results incl. tables

Table 1: Erythema and edema scores after 1 and 4 h of exposure

Animal No. 1 2 3 1 2 3
  Erythema Edema 
1 h exposure
1 h 0 0 0 1 1 0
24 h 0, h 1,h 1,h 0 0 0
48 h 0 1,h 0,h 0 0 0
72 h 0 1 2 0 0 0
7 days 0 0 2 0 0 1
14 days 0 0 0 0 0 0
Score 24/48/72 h 0.0 1.0 1.0 0.0 0.0 0.0
4 h exposure
1 h 1 1 1 1 2 1
24 h 2,h 2,h 2,h 1 1 1
48 h 3 2,h,d 3,h 1 1 1
72 h 3 1,h,d 3 1 1 2
7 days 1,c,s > 4,s 2,s 0 0 1
14 days 0 1,f 0 0 0 0
Score 24/48/72 h 2.7 1.7 2.7 1.0 1.0 1.3
c: cracking areas; d: dark areas; f: flanking skin; s: shiny areas; > 4,s: severe eschar; h: test article residue

Applicant's summary and conclusion

Interpretation of results:
other: Skin Irrit. 2 (H315) according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: Skin Irrit. 2 (H315)