Registration Dossier

Administrative data

Description of key information

In vitro skin irritation (OECD 431), human skin model test (EpiSkin): not corrosive

In vitro skin irritation (OECD 439), human skin model test (EpiSkin): irritating

In vitro skin irritation (OECD 439), human skin model test (EpiSkin): not irritating

In vivo skin irritation (OECD 404), rabbit: not irritating

In vivo eye irritation (OECD 405), rabbit: severely irritating (irreversible) (read across from CAS 1760-24-3)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-06-01 to 2017-07-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
28 July 2015
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 20-21 weeks
- Weight at study initiation: > 3.9 kg
- Housing: ABS-plastic or Noryl rabbit cages; not reported how many animals housed per cage
- Diet: Altromin 2123 maintenance diet for rabbits provided ad libitum
- Water: Municipal drinking water provided ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
In an initial test, one animal was exposed to the test material for 3 minutes, 1 hour, and 4 hours without any reactions being observed. For the experiment, the second animal was exposed to the test material for 4 hours.
Observation period:
72 hours initially; the observation period was extended for animal no. 1 to 6 days and 5 days for animal no. 2 in order to evaluate the reversibility of lesions
Number of animals:
2 males
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk (6 cm2)

- Type of wrap if used: treatment area covered with gauze patch and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: Test material was removed by using cottonseed oil for animal no. 1; there was no residual test material to be removed from animal no. 2.
- Time after start of exposure: at the end of the exposure period for animal no. 1

OBSERVATION TIME POINTS
0 hr, 1 hr, 24 hr, 48 hr, 72 hr, day 4, day 5, day 6

SCORING SYSTEM:
Erythema and eschar formation: no erythema = 0; very slight erythema = 1; well defined erythema = 2; moderate to severe erythema = 3; severe erythema to eschar formation preventing grading of erythema = 4
Edema formation: no edema = 0; very slight edema = 1; slight edema = 2; moderate edema = 3; severe edema = 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
There were no significant effects on body weight.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.
Conclusions:
In an in vivo skin irritation study according to OECD guideline 404 and in compliance with GLP, the mean (24-72 hours) erythema score observed in 2 animals was 1; the mean (24-72 hours) edema score for the same animals was 0. All irritation was reversible within 6 days. Therefore, the test item should not be classified as an irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Irritation parameter:
other:
Basis:
other: 5 animals
Time point:
24 h
Score:
3
Max. score:
10
Remarks on result:
other: 0.1 mL: mild or moderate corneal injury with iritis. 0.5 mL: moderate corneal injury with iritis. Grade 3.
Remarks:
CAS 1760-24-3, Mellon Institute, 1975
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
not fully reversible within: 30 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Huls AG, 1993
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 30 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Huls AG, 1993
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 30 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Huls AG, 1993
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 30 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Huls AG, 1993
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye.
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
cornea opacity score
Basis:
animal: Animals 2, 3, 4, 5 and 6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Ulceration. Presence of a whitish humour on the side of the lids of the treated eye. Varying areas of neovascularisation of the cornea.
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animals 1 reversed between Day 14 and 21, but all others had Grade 1 on Day 21. Circ umcorneal injections with/out congestion of the iris. Also some animals had permanent myosis with preservation of the direct photomotor reflex.
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
chemosis score
Basis:
animal: Animals 2, 3 and 5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 1 on Day 21. Depilation area around the lids of the treated eye.
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Grade 2 on Day 21. Depilation area around the lids of the treated eye.
Remarks:
CAS 1760-24-3, Hazleton France, 1993
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
2.4
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981b
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981b
Irritation parameter:
other:
Score:
8
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: Moderately severe corneal necrosis from 0.005 ml undiluted or excess (0.5 ml) of a 15% soluti on in propylene glycol. A 5% solution caused no injury in 2 eyes and only traces of diffuse corneal necrosis in 3 others.
Remarks:
CAS 1760-24-3, Mellon Institute, 1966
Irritation parameter:
cornea opacity score
Basis:
animal: 1 (not washed)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 until Day 4 reading which was Grade 2. On Day 14: Grade 1.
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
iris score
Basis:
animal: 1 (not washed)
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
conjunctivae score
Basis:
animal: 1 (not washed)
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
chemosis score
Basis:
animal: 1 (not washed)
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
cornea opacity score
Basis:
animal: 2 (washed)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
cornea opacity score
Basis:
animal: 3 (washed)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
cornea opacity score
Basis:
animal: 4 (washed)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 2 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 2 on Day 14
Remarks:
CAS 1760-24-3, TNO, 1984
Irritation parameter:
cornea opacity score
Basis:
animal: 1 and 2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Pannus
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: From Day 7 grade 1 opacity was evident, which had worsened to Grade 2 on Days 13 and 14. Day Pannus from Day 7.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Grade 1 opacity from Day 9. Pannus on Day 7.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Grade 1 opacity on Day 7, which worsened to Grade 4 on Days 8 to 14. Pannus from Day 4.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Grade 2 opacity on Day 7, which worsened to Grade 3 on Days 9 to 14. Pannus on Day 7.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Score of 1 at 48 hours, 0 at 72 hours, 1 on Day 4 and 0 on Day 7 and thereafter.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: Cannot evaluate
Remarks on result:
other: Grade 1 opacity on Days 1, worsened to Grade 2 on Days 8 to 10. Thereafter the iris was impossible to evaluate due to the opacity.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: Cannot evaluate
Remarks on result:
other: Grade 1 opacity until Day 10. Thereafter the iris was impossible to evaluate due to the opacity.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: Also blistering of the conjunctivae.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Grade 2 remained on Day 14. Also blistering of the conjunctivae.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 13 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
conjunctivae score
Basis:
animal: 4 and 5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Grade 2 remained on Day 14. Blistering of the conjunctivae.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Grade 2 remained on Day 14. Also blistering of the conjunctivae.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 remained on Day 14.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other:
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 remaining on Day 14.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 2 on Day 14.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Grade 1 on Day 14.
Remarks:
CAS 1760-24-3, ToxiGenics Inc., 1981a

Eight further in vivo eye irritation studies are available for CAS 1760 -24 -3. All of them show severe eye damage after eye expsoure.

Interpretation of results:
other: CLP/EU GHS criteria are met, Category 1 classification is required according to Regulations (EC) No 1272/2008.
Conclusions:
In the key study for eye irritation conducted to OECD 405 and to GLP (Hazleton, 1993) the source substance N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) was severely irritating (irreversible) to the eyes of rabbits. Five of the six tested rabbits had serious effects on the eye that were not reversible in within the 21 day observation period. These effects included ulceration and congestion of the cornea and circumcorneal injections. This result is supported through several further eye irritation studies in rabbits. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in acute dermal toxicity potential.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Multiple in vitro skin irritation studies were conducted according to guideline and in compliance with GLP with the test material 1,2-ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivs,hydrochlorides (CAS 171869-89-9). Studies included one OECD 431 study and two OECD 439 studies. The OECD 431 study demonstrated that the test material was not corrosive; however, the two OECD 439 studies showed conflicting results. In one of the in vitro OECD 439 studies, a cell viability of 77.2% was measured when compared to the untreated control (Eurofins, 2017b). Therefore, the test item was not considered an irritant. In the remaining in vitro OECD 439 study, a cell viability of ≤ 50% was measured when compared to the untreated control (Eurofins, 2017a). Therefore, the test item was considered an irritant. Based on the results of these in vitro studies, it was deemed necessary to conduct an in vivo skin irritation study.

In an in vivo skin irritation study according to OECD guideline 404 and in compliance with GLP, two male rabbits were exposed to 0.5 mL of the test material for 4 hours under semi-occlusive conditions. The mean (24/48/72 hours) erythema score observed in 2 rabbits was 1; the mean (24/48/72 hours) edema score for the same animals was 0. All irritation was reversible within 6 days. Therefore, the test item should not be classified as an irritant.

 

Eye Irritation

No data on eye irritation is available for 1,2-ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides (CAS 171869-89-9). Therefore, the risk assessment was performed based on the available data from the source substance, N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances has been applied to support the human health hazard assessment of 1,2-ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides (CAS 171869-89-9). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.

In the key study for eye irritation conducted to OECD 405 and to GLP (Hazleton, 1993) N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) was severely irritating (irreversible) to the eyes of rabbits. Five of the six tested rabbits had serious effects on the eye that were not reversible in within the 21 day observation period. These effects included ulceration and congestion of the cornea and circumcorneal injections.

Several reliable supporting studies for eye irritation were also available, all conducted according to current guidelines and in compliance with GLP. The majority of the studies reported severe, irreversible effects on the eyes of the animals (CIT 1994, Huls 1993, Huntington Research Center Ltd, 1994). Corrosive effects reported included a delayed manifestation of a grade 4 corneal lesion lasting until the end of the observation period. Conjunctival blistering was also reported (Toxicogenics Inc., 1981). Irreversible effects in the eyes of rabbits were reported even following washing of the eyes four seconds after treatment (TNO, 1984).In addition, a reliable pre-GLP eye irritation study which administered the test substance neat caused what was described as minor irritation to the eyes of rabbits (Mellon 1975).

Based on all available data N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) is shown having eye damaging properties. The same conclusion is drawn for the target substance 1,2-ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivs,hydrochlorides (CAS 171869-89-9).

Justification for classification or non-classification

The available data on skin irritation indicate that 1,2 -ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivs,hydrochlorides do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.

Reliable data from a structural analogue on eye irritation indicates that the registered substance meets the criteria for classification according to Regulation (EC) No. 1272/2008, and the available data are therefore classified as Eye Damage Cat. 1 (H318).