Registration Dossier

Administrative data

Description of key information

Corrosive to the skin after exposure of 1, 5, 15 min, or 20h - effects were independent of exposure time and washing steps with Lutrol.

Damages the eyes.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.48 kg; male 2.53 kg
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1, 5, 15 min and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
Irritation parameter:
erythema score
Remarks:
1, 5, and 15 min exposure
Basis:
mean
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
1, 5, and 15 min exposure
Basis:
mean
Time point:
other: 8 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe scaling, parchment skin
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3 - 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: marked necrosis and severe redness extending far beyond the area of exposure
Irritation parameter:
edema score
Remarks:
1, 5, and 15 min exposure
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
1, 5, and 15 min exposure
Basis:
mean
Time point:
other: 8 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: extending far beyond the area of exposure
Irritant / corrosive response data:
After 8 days the skin has a parchment-like necrosis that extends far beyond the area of exposure, the surroundings show severe erythema and edema when exposed to a maximum of 15min.
Exposure for 20h leads to severe necrosis.
Interpretation of results:
highly corrosive
Remarks:
Migrated information
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was either left untreated or washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean 3,2 kg
- Diet: ad libitum (Ssniff K standard diet)
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
Experiment 1: 1, 5, 15 min (washed) and 20 h (untreated)
Experiment 2: 1, 5, 15 min, either washed or untreated
Observation period:
8 days
Number of animals:
2 per treatment duration (14 in total)
Details on study design:
Experiment 1: A patch with the test substance was applied to the back skin for the given amount of time. After 1, 5, and 15 min, the test site was first soaked in Lutro and then washed with 50% Lutrol in water.
Experiment 2: This experiment was designed to examine the effect of washing. Animals were treated with two patches of the test substance each on both flanks. The two treatment sites on one flank were left untreated, the other two were first soaked in Lutrol and then washed with warm water directly after the end of exposure.
Irritation parameter:
erythema score
Remarks:
1, 5, and 15 min, and 20 h exposure
Basis:
mean
Remarks:
Exp. 1
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: exposure time had no effect on the results
Irritation parameter:
erythema score
Remarks:
1, 5, and 15 min, and 20 h exposure
Basis:
mean
Remarks:
Exp. 1
Time point:
other: 8 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
parchment-like slight necrosis extending far beyond the area of exposure
Remarks on result:
other: exposure time had no effect on the results
Irritation parameter:
edema score
Remarks:
1, 5, and 15 min, and 20 h exposure
Basis:
mean
Remarks:
Exp. 1
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
extending far beyond the area of exposure
Irritation parameter:
other: Necrosis
Remarks:
1, 5, 15 min exposure
Basis:
mean
Remarks:
Exp. 2
Time point:
other: 8 days
Reversibility:
not reversible
Remarks on result:
other: leather-like or hard necrosis, rhagade-like cracks, partly aneamic areas, extending far beyond the exposure area
Irritation parameter:
edema score
Remarks:
1, 5, 15 min exposure
Basis:
mean
Remarks:
Exp. 2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: exposure time had no effect
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Remarks:
Exp. 2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Remarks:
Exp. 2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Remarks:
Exp. 2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Independent of the exposure time similar effects were observed. In the beginning, severe eryhthema and edema were signs of a strong inflammatory reaction that led to necrosis within the following 8 days.
No difference was observed between the sites that were left untreated or immediately washed after exposure. This might be due to the fact that the test substance is neither soluble in Lutrol nor water, but might adhere to the skin due to its highly lipophilic properties.
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF test
50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min., 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.35 kg; female: 2.31 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h - 8 d
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 8 d
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 8 d
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
Iritis
Irritant / corrosive response data:
Further observations after 24 hours and 8 days: severe redness, distinct edema and severe opacitity, including haemorrhages, staphyloma and suppuration
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Skin irritation

In a skin irritation test comparable to OECD guideline 404, di-tridecanamine was applied to the skin of Vienna White rabbits for 1, 5, 15 min or 20 hours (using 2 animals at all exposure durations) under occlusive conditions and observed for 8 days (BASF AG, 1970). Application caused severe erythema extending beyond the area of exposure and distinct edema after 1, 5 and 15 min of exposure. Dermal application for 20 hours induced a parchment-like necrosis that extends far beyond the area of exposure, the surroundings showed severe erythema and edema after 24 hours and after 8 days. Di-trideancamine was judged highly corrosive to the skin.

In a second study comparable to OECD 404 (BASF 1977), the flanks of white rabbits were exposed to the test substance for 1 minute, 5 minutes, 15 minutes, and 20 hours in the occluded patch test. The same qualitative findings were obtained irrespective of the exposure period. Severe to very severe erythema and edema at early time points were indicators of a severe inflammatory reaction which led to the formation of necrosis in the course of 8 days. The intensity of the inflammatory reaction was not reduced by washing with Lutrol. It must however be noted that the test substance is insoluble in Lutrol and water, so that the efficiency of the washing step must be questioned. Based on the severe reactions already after 1 min of exposure, di-tridecanamine was considered highly corrosive to the skin.

Three in vitro tests were carried out, the results of which were all considered false negative due to the reasons given below.

  • Two in vitro tests to assess the skin corrosion potential of Tridecanamine, N-tridecyl-, branched and linear were conducted (2018) according to OECD 431. The studies were carried out to compare the toxicological properties of two batches of the UVCB DTDA. Two EpiDerm ™ tissues per exposure time were treated with 50 μL undiluted liquid test substance. The tissues were exposed for 3 minutes and 1 hour. For DTDA PSN 18/0020 -1 the mean viability after 3 min was 95.1% and 64.2 % after 1 hour exposure. For DTDA PSN 18/0019-1 the mean viability after 3 min was 104.2% and 58.3% after 1 hour exposure. Based on the results observed and by applying the evaluation criteria, it was concluded that both batches did not show a skin corrosion potential under the test conditions chosen.
  • In a corrositex assay (BASF 2014) according to OECD 435, no change in the color of the detecting solution (pH indicator dyes) were observed in four vials within 60min. Consequently, tridecanamine, N-tridecyl-, branched and linear was considered to be non-corrosive.

The results were considered false negative, because:

  1. In vivo, severe inflammation is observed days before necrosis occurs. Neither inflammation nor a delayed reaction would be observed in the in vitro experiments.
  2. It is hypothesized, that the substance does not (primarily) act as a base, but is dissolved in cell membranes eventually damaging the cells. Degradation  / metabolism / excretion are expected to be very slow, which would explain the worsening of effects in vivo over a long time period even after exposure for only 1 minute, as well as reactions far beyond the application area. This effect can not be detected in the corrositex assay, and it is questionable, if it could be seen in an epiderm test.
  3. Even though a compatibility test was performed in the corrositex assay (i.e., a color change was observed, when the substance was directly applied to the detection solution), the results have not been described. Considering that the substance is an UVCB and most of its components are completely insoluble in aqueous solutions, a change in pH value seems unlikely or would have been caused only by a minor fraction. If only some of the other components managed to diffuse through the membrane, no change in the detecting solution would have been noticed.

Eye irritation

In an eye irritation test comparable to OECD guideline 405, di-tridecamine was applied to conjunctival sac of the eyes of 2 Vienna White rabbits (BASF AG, 1970). Animals were observed after 1 and 24 hours and up to 8 days after the treatment. The application caused corrosion, expressed by severe redness and corneal opacity, iritis, and very severe edema. Di-tridecamine was judged corrosive to the eyes.

Justification for classification or non-classification

Tridecanamine, n-tridecyl, branched and linear caused necrosis after just on minute of exposure on the skin. Even though the first skin reaction was severe inflammation and necrosis took severeal days to manifest (missing the GHS criterium of < 1h), the fact that washing had no effect and very short exposure times were sufficient to irreversibly damage the skin, GHS category 1A was still assigned. Additionally, the registered substance is classified to damage the eyes (category 1) according to CLP Regulation (EC) No. 1272/2008.