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Description of key information

Skin irritation/corrosion properties of test material was determined with an in vitro and an in vivo study. The in vitro study was conducted according to OECD 435 Corrositex (MB Research 2017). The in vivo study was conducted in 2006 and was based on OECD 404 (MB Research 2006). Both studies revealed corosive properties of the test compound.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2005-11-29 to 2005-12-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Benzylated polyamine, lot # 20245-1-1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals received from Milbrook Breeding Labs, Amherst, MA, pre-test weight 2.7-3.0 kg,
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml per site
Duration of treatment / exposure:
3 minutes - 1 hour - 4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
Day before application 3 sites (approximately 3x3 cm) on back of test animal were clipped free of hair.
Initially one rabbit was dosed on one site for 3 minutes.
Since no evidence of corrosive effect was observed, 2 additional animals were added to the study.
All three animals were dosed 0.5 ml of test article on site #2 for one hour and on site #3 for four hours.
Residual test article was removed after exposure period by washing with distilled water.

Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
2.7
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
2.7
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
4
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
1.3
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
2.3
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
2
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
14 d
Score:
2
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2.6
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
4
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
4
Max. score:
5
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
2.6
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
2.6
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2.6
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
2.3
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
14 d
Score:
2
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: 4 h exposure
Conclusions:
Skin irritation/corrosion properties of test material, carbomonocyclic alkylated mixtures of poly-aza-alkanes, hydrogenated, was determined using OECD 404 Acute dermal irritation/corrosion method using 3 white New Zealand rabbits. Based on study results material was classified as moderately corrosive.
Executive summary:

The test was performed to determine if the test material causes irreversible damage to rabbit skin. The study was conducted according to OECD guidelines No. 404 acute dermal irritation/corrosion modified to include a one-hour exposure period in order to provide data for assignment of packing groups. Initially one healthy new zealland white rabbit was doses with the test material. The test material was kept in contact with the skin for three minutes and scored for erythema and edema one hour following patch removal, at 48 h and 72 h, and on day 7 and 14. Since the three minute exposure did not produce a definitive effect, two additional rabbits were added to the study. All three animals were dosed at site 2 for an exposure period of 1 hour and at site 3 for four hour exposure. Each site was scored forerythema and edema one hour following patch removal, at 48 h and 72 h, and again on day 7 and 14. The animals were observed for systemic signs at each dermal scoring interval. A modified primary irritation index was calculated. Body weights were recorded pretest and at termination.

After 1 hour exposure erythema was very slight to well defined at 1 hour , well defined at 24 h hours after exposure and well defined to severe at 48 h and 72 h after expsoure. Erythema was severe on days 7 and 14 and included instances of moderate to severe eschar. Additionally black areas and shiny skin with poor hair regrowth were noted. edema was very slight to slight at 1 hour after the 1 hour expsoure, well defined to moderate at 24 hours and well defined at all subsequent observation periods. Erythema was well defined to moderate at 1 hand 24 h after the 4 hour expsoure and severe at all subsequent observation periods. Additionally moderate to severe eschar was noted and pale and black areas of the treated skin. Edema was well defined at 1 h after the 4 h expsoure and well defined to moderate at all subsequent observation periods.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-05-05 to 2017-06-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes (incl. certificate)
Test system:
artificial membrane barrier model
Justification for test system used:
Qualification
For each test article, 150 μl or 100 mg of the test article were added to the CDS reagent in a Qualify vial,
and the vial was observed for any notable color change. An observable color change indicates that the
test article is compatible with the Corrositex® system.
Vehicle:
unchanged (no vehicle)
Details on test system:
TEST SYSTEM
Identity : Corrositex® Kit
Supplied by : InVitro International, Placentia, CA
Lot Numbers : CT 060115 and CT 120516
Dates Received : 06 Oct 2015 and 14 Feb 2017
Expiration Dates : Jun 2017 and Dec 2018
Storage : Refrigerated at 2-8ºC
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
100 μl of the test article were added to
900 μl of tissue culture water and mixed to yield a 10%
formulation. The test article was also used as received.
Number of replicates:
4
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
48.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
2
Value:
48.35
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
3
Value:
48.37
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
4
Value:
48.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
5
Value:
48.38
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
Skin irritation/corrosion properties of the test material benzylated polyamine was determined using Corrositex® method. The test material showed a break through time of 48.38 min.
Executive summary:

The objective of the test was to determine dermal corrosivity and assign U.N. Packing Group classification for chemicals or mixtures. This study is designed to comply with the standards set forth in the OECD Guideline for the Testing of Chemicals No. 435.The test article was qualified and found to be compatible with the Corrositex® test system. The test article was then categorized by pH. Then 500 μl of the test article were added to each of four Corrositex® test vials containing biobarriers and the times required for each test article to penetrate or destroy the biobarriers were recorded. A positive control (1.0 N sodium hydroxide) and a negative control (1% citric acid) were tested concurrently. The mean breakthrough time, which predicts the in vivo corrosive potential, was used to designate the United Nations (U.N.) Packing Group classifications and GHS Sub-category.

The 1.0 N sodium hydroxide positive control had a breakthrough time of 18.00 minutes, which fell within the range allowed. The 1% citric acid negative control had a breakthrough time of >92.83 minutes, which met the acceptance criterion of >60 minutes. The benzylated poly amine has a mean breakthrough time of 48.38 min and was therefore classified as skin corrosive Cat. 1B and assigned to packing group 2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation/corrosion properties of test material, carbomonocyclic alkylated mixtures of poly-aza-alkanes, hydrogenated, was determined by using Corrositex® method and an in vivo study according to OECD 404. Based on break through time of  48.38 min in the Corrositex assay, material was classified as moderately corrosive (GHS Corr. cat. 1B).